Transcript
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Graz- November 9th. 2O1Z
LETTER OF AUTHORIZATIONcrAY uy euyEN
We, AMEDA Labordiagnostik GmbH, having facilities at Krenngasse 12, g010
Graz, Austria, as the legal manufacturer (product owner) of medical devices as listedbelow hereby authorize ANH QUAN TECHNOLOGY & TRADING CO., LTD of No. 74,Alley: 69A/ 48, Hoang Van Thai Street, Thanh Xuan District, Ha Noi, Vietnam, tocirculate medical devices as listed in the attachment in Viet Nam market.
Chf ng t6i, AMEDA Labordiagnostik GmbH, c6 cd sd tai Krenngasse 12, BO10
Graz, Ao, lir nhi s6n xu5't hdp phdp cua cdc thi6t b! y td nhr./dr-/Qc liet kC dL/6i d6y uyquyEn cho C6ng ty TNHH Thudng MEi vi C6ng NghQ Anh Qudn tai Sd 74 ng6 69A/48,Hoing Vdn Thdi, Thanh Xu6n, Hi NOi, Viet Nam dr/Qc |t/u hdnh cdc thi6t bi y td nhU dL/qc
liCt ke trong phHn dinh kdm tai th! trr/dng ViCt Nam.
We commit to providing and supporting any request relating to information andquality of medical device as well as ensuring the right conditions for operation,maintenance, and material replacement fo'r above said medical devices.
Chung t6i cam k6t cung cd1, h5 trO cdc y6u cbu li€n quan ddn th6ng tin, ch6't lUdngvir bao dam cdc diEu ki€n vE biio hinh, b6o tri, bao dr.fdng vd cung c6'p v6t tr/, phq ki6nthay th6 cdc trang thi6t bi y td n€u tr6n.'
The letter of authorization has a validity until 31.12.2oL9.
ThrJ uy quyEn niy c6 hi6u lq/c ddn thdi didm 31.I2.20L9
Premstdtten - 09 .LL.2Ot7
AMEDA Labordiagnostik GmbH
AMEDA Labordiagnostik GmbHKrenngasse 12,8010 Graz / Austria * Phone +43-316-69 80 69 * Fax +49-316-69 80 69 12 * www.amp-diagnostics.comE-mail: ffice.graz@amp-med.com * Registration no.: FN 339703p at Commercial Court Graz * VAT No.: niUOSggOgO+
Attachment to Letter of Authorization
Clinial Chemistry ReagenbRoutine Chemisfrv
RE / tut tn Mud rpne / hnmetu Method
09.tt.2017
Aur.Reag. Vol, Format
8R0101 Acid Phosphqb_sq _ _ lEqS f€ fo_ts'et)I fd_tstgltl_ 10" 19x10ml lx5mL( 5 mL 1 x 15 mL 100 powder
8R0205_ _ 4E PjgspltgQ9g]9F:9(D_E4)___51*5LqgK!'gcEL____1.l0gT! __U1-2T! __gs__-lqgl
8R0200 elf-.Ptrospnalar.?oenl8R0201 Alk.Phosphatase (DEA)
8R0202 Alk.Phosphatase (DEA)
8R0611 AST / @T8R0612 'AST/COr
8R0800 Amylase8R0801 AmylaseBR0802 Amylase
BROgOO CK NAC
BROgOl CK NAC
8R1200 Gamma GT8R1201 Gamma GT8R1202 Gamma GTBRl.205 Gamma GT
Kinetic ( DGKC, SCE )
Kinetic ( DGKC, SCE )
Kinetic ( DGKC, SCE )
Kinetic (IFCC)
Kinetic (IFCC)
Kinetic (IFCC)
Kinetic (CNP-G3)
Kinetic (CNP-G3)
L-g-Glutamyl-p-nitroan ilide
L-g-Glutamyl-p-nitroanil ide
L-9-Glutamyl-p-nitroa ni lide
L-g-Gl utamyl-p-nitroan i lide
4x25mL 2 x 12.5 mL
2x50mL 1x25ml4x50mL 2x25mL
4x25mL
2x50mL
4x50mL
4x25mL
2x50mL
4x50mL
4x 25mL
2x50mL
4x50mL
5x100mL
2 x 12,5 mL
1x25mL
2x25mL
2 x 12.5 mL
1x25mL
2x25mL
2 x 12.5 mL
1x25mL
2x25 mL
1x125mL
L25 liquid
L25 liquid
250 liquid
L25 liquid
725 liquid
250 liquid
t25 liquid
125 liquid
250 liquid
.__BBq2gs__4Elh9sp!9E99lIl9SI__ILeul________ __sx100mL lxr5ml 6zs lqurd
8R0290 Alk.Phosphatase (IFCC) Kinetic
BR029f Alk.Phosphatase (IFCC) Kinetic
8R0292 Alk.Phosphatase (IFCC) Kinetic
BRO41O ALT / GPT
BR0411 ALT / GPT
8R0412 ALT / GPT
725 liquid
L25 liquid
250 liquid
625 liquid
2x50mL 1x25mL
125 liquid
125 liquid
250 liquid4x50mL 2x25mL
romL 1x125ml125 mL 625 liquid
50 liquid
150 llquid
150 liquid
100_ - -lqgq
. _ _qEg!s_ _ ALf/ 9T_ _ _ !L.tt9 gFgc)_ _ 1"l0gT! _ _t 1-2T!8R610 AST / GOT Kinetic (IFCC) 4 x 25 mL 2 x 12.5 mL
. _ _qE$ls_ _ 4:I/ Sqr_ - _ !trtj: gFgc)
Kinetic (IFCC)
Kinetic (IFCC)
strtj: gFgcl _ l"jogTlKinetic (CNP€3) I x 50 mL
6x25mL
3x50mL
6x50mL
Iinltf, GrZcloZ[ct - - - - Zizs-'T - -z;.il.s ",r
Kinetic ( IFCC, DGKC ) 2x50mL 1x25mL
.__BBWq3__-$nylasp. I Kinetic (CNP-G3)
.__BBEq2__!|!.1\A9 _Ii}"ttseFr9.Tlcl__ __lfoj: __rj3s]L___8R1100 CK MB NAC Immuno-inhibition 4 x 25 mL 2 x 12.5 mL
1x25mLBRllOl CK MB NAC Immuno-inhibition 2 x 5o mL
125 liquid
125 llquid
8R1102 CK MB l.|Ac Immuno-inhibition 4 x so mL 2 x 2s mL zfl thdd
725 hq'id
125 liquid
250 liquid t
625 liquid
8R1422 LDH-L l(netic (IrcC) 4 x s0 mL 2 x 2s mL 2s lrqurd
BR142O LDH-LBR1421 LDH-L
BR 45O LDH.P
BRT451 LDH-P
BRrYn LipaseBRIS(X}S LipaseBRlg)l Lipase
8R1501-S Lipase
BRf502 Upase8R1502-S Lipase
8R2110 Elilirutrin totalBR2lflS Efilirutin total8R2111 EfiliruUn total
BR2f lf-S Bilirutrin total8R2112 Efilirubin total
8R2210 Elifirubin total & directBR221GS Bilirubin total & directWJ.2L2 Bilirubin total & direct
8R2212-S Bilirubin total & direct
Kinetic (IFCC)
Kinetic (IFCC)
Kinetic (SFBC)
Kinetic (SFBC)
Kinetic (Methylresorufi n)
Kinetic (Methylresorufi n)
Kinetic (Methylresorufi n)
Kinetic (Methylresorufi n)
Kinetic (Methylresorufin)
Kinetic (Methylresorufi n)
Sulphanilic acid
Sulphanilic acid
Sulphanilic acid
Sulphanilic acid
Sulphanilic acid
Sulphanilic acid
Sulphanilic acid
Sulphanilic acid
4x25mL 2x12.5m1
2x50mL 1x25mL
4x25mL 2x12.5m1
2x50mL 1x25ml
1x15mL 1x3ml1x15ml 1x3ml1x25mL lx5mL1x25ml 1x5mL
2x25ml 2x5mL
2x25ml 2x5mL
2x10ml 1x10mL
2x10mL 1x10mL
2x25mL 1x25mL
125 liquid
125 liquid
I25 liquid
L25 liquid
18 liquid
1 x 1 mL 18 liquid
30 liquid
1 x 1 mL 30 liquid
60 liquid
1 x 1 mL 60 liquid
30 liquid
1 x 1 mL 30 llquid
75 liquid
75 liquid
L25 liquid
1x 1 mL 725 liquid
125 liquid
1x 1 mL L25 liquid
250 liquid
725 liquid
1 x I mL 125 liquid
8Rf452 LDtl-P l(netic (SFBC) 4 x s0 mL 2 x 2s mL zso lhurd
BRl6m Adencine Deaminase Enzymatic
BRIflDS Adenosine Deaminase Enzymatic
8Rf601 Adenosine Deaminase Enzymatic
_q$Jqof-!_4,qflgeLe_qgalnlnass___lEyryt__ _3YsJf __L"3Il_- IAIL_
_S?g?-!_glCq!'logl_______gl4!t"J.!_______1t'0j!_____,_]3jr______:tgr-___30__lhgd__
4x25mL
4x25mL
2x50mL
2x50mL
4x50mL
4x25mL
4x25mL
4x50mL
2 x 12.5 mL
2 x 12.5 mL
1x25mL
1x25mL
2x25mL
2 x 12.5 mL
2 x 12.5 mL
2x25mL
AITEDA labordiagnostik Gm bHa
250 liquid
:,{pETIr.! -lfoiL __ri3sjl___ 3f$___T0__]iq*d_-
Page 1 of7
AtFchment to Letter of Authorization 09.rL.20L7
E / Fzittn Muctname / Parameter
8R2410 Bilirubin direct8R2410-S Bilirubin directBR24l1 Bilirubin direct
BR24f 1-S Bilirubin direct8R2412 Bilirubin direct
8R2841 Creatinine8R2841-S CreatinineBR2&{3 Creatinine
R2843-S Creatinine
A&7 Creatinine
BR2!)fr) Glucose PAP
il2IXXFS Glucose PAP
n2!nf Glucose PAP
n2q)l-S Glucose PAP
nZn3 Glucose PAP
n2!Xl}S Glucose PAP
n29O6 Glucose PAP
il2lXFS Glucose PAP
m29f0 Glucose PAP
n2920 Glucose PAP
t2940 Glucose PAP
Method
Sulphanilic acid
Sulphanilic acid
Sulphanilic acid
Sulphanilic acid
Sulphanilic acid
Kinetic (Butyrylth iochol i ne)
Ki netic (Butyrylth iochol i ne)
Alkaline picrate (Jaffe)
Alkaline picrate (Jatre)
Alkaline picrate (Jaffe)
Alkaline picrate (Jaffe)
Alkaline picrate (Jaffe)
Alkaline picrate (Jaffe)
Alkaline picrate (Jaffe)
Alkaline picrate (laffe)
Alkaline picrate (Jaffe)
Alkaline picrate (laffe)
Glucose oxidase
Glucose oxidase
Glucose oxidase
Glucose oxidase
Glucose oxidase
Glucose oxidase
Glucose oxidase
Glucose oxidase
Glucose oxidase
Glucose oxidase
Vol. Format4 x25 mL
4x25mL
2x50mL
2x50mL
4x50mL
4x25mL
2x50mL
2 x 12.5 mL
2 x 12.5 mL
1x25mL
1x25mL
2x25mL
2 x 12.5 mL
1x25mL
2x25 mL
1x125mL
1x1mL
lx1mL
L25
t25
I25
t25
2s0
liquid
liquid
liquid
liquid
liquid
liquid_S?!l?-9_9i!irqbj!!'Iegt_ :,.!qE.r!Tcld__ __1f0Jl __rj31l 2x1mL 250
Kinetic (Butyrylthiocholine) 4 x 50 mL
8R2515 CholinesteraSe Kinetic (Butyrylthiocholine) 5 x 100 mL
8R2510 Cholinesterase
8R2511 Cholinesterase
8R2512 Cholinesterase
8R2600 Cholesterol PAP
BR26OGS Cholesterol PAP
8R2601 Cholesterol PAP
BR260f-S Cholesterol PAP
8R2603 Cholesterol PAP
BR26O3-S Cholesterol PAP
8R2606 Cholesterol PAP
8R266S Cholesterol PAP
8R2610 Cholesterol PAP
8R2520 Cholesterol PAP
8R2640 Cholesterol PAP
Bflc'Ttl Carbon Dioxide PEPC
8R2830 Creatinine
BR283GS Creatinine8R2832 Creatinine
8R2832-S Creatinine
8R2836 Creatinine
Chol.Esterase/Chol.Oxidase 6x25mL
Chol.Esterase/Chol.Oxidase 6x25mL
Chol.Esterase/Chol.Oxidase 1x100mL
Chol.Esterase/Chol.Oxidase 1x100mL
Chol.Esterase/Chol.Oxidase 3x100mL
Chol.Esterase/Chol,Oxidase 3x100mL
Chol.Esterase/Chol.Oxidase 6x100mL
Chol.Esterase/Chol.Oxidase 6x100mL
Chol.Esterase/Chol.Oxidase 4x250mL
Chol.Esterase/Chol.Oxidase 4x500mL
Chol,Esterase/Chol.Oxidase 4x1000m1
t25 liquid
125 liquid
250 liquid
625 liquid
1x3mL
1x3mL
1x5mL
2x5mL
150 liquid
150 liquid
100 liquid
100 liquid
300 liquid
300 liquid
600 liquid
600 liquid
1000 liquid
2000 liquid
4000 liquid
6x25mL
4x25ml 2x10ml4x25ml 2x10ml4x50mL 2x20ml4x50mL 2x20ml5x125mL 1x125mL
150
150
liquid
liquid
1x3mL
1x5mL
L20
120
240
240
750
750
liquid
liquid
liquid
liquid
liquid
liquid_s?q3q9_9rse!i!!Le_ __!Er'gpicrateg.x"l _1"1?t __t3sJ! __3fI\
_ S3q4Z-9 _ 9pqliUrc Akarrne pigale !l.f,.l _ 1"12:T! _ _3 " 13sJ!n2851 Creatinine PAP Enzymatic z x 60 mL 1 x 40 mL
_ _q{l$_ _ -9rSq!iUte!AP_ !ryry1c_ _ _ 1"j2gt _ _ 1119091_ _
3x25mL
3x25mL
3x50mL
3x50mL
3x125mL
1x60mL
3x60mL
3x30mL
8x30mL
3x25mL
3x25mL
3x50mL
3x50mL
3x125mL
1x3mL
1x5mL
2x5mL
150 liquid
150 liquid
300 liquid
300 liquid
750 liquid
750 liquid
160
320
liquid
liquid
6x25mL
6x25mL
1x100mL
1x100mL
3x100mL
3x100mL
6x100mL
6x100mL
4x250mL
4x500mL
lx3mL
1x3mL
1x5mL
2x5mL
150 liquid
150 liquid
100 liquid
100 liquid
300 liquid
300 liquid
600 liquid
500 liquid
1000 liquid
2000 liquid
4000 liquid!t:So:e315ta1ffin7 Glucose HK
Kn7-S Glucose HK
8R3202 HDL Cholesterol direct8F32(B HDL Cholesterol direct
8R3251 HDL Cholesterol8R3252 HDL Cholesterol
Hexokinase 6x125mL
Hexokinase 6x125ml
Direct Clearance
Direct Clearance
Precipitant reagents
Precipitant reagents
1x15mL
3x15mL
750
_ _:f rL_ - -7:0_1x1mL
1x1mL
liquid
liquid
75 liquid
225 liquid
900 liquid_ BR3_210_ _ ltQl_clolegtqrglli1egt liEqlEqt Te_ _ _ _ :3:6ge _ _?{sJ!1x5mL
2x5mL
90
240
liquid
liquid
8R3302 LDL Cholesterol direct8R3308 LDL Cholesterol directBRBf0 LDL Cholesterol direct
Direct Clearance
Direct Clearance
Direct Clearance
1x60mL
3x60mL
12x60mL
1x15mL
3x15mL
12x15mL
1 x 1 mL 75 liquid
1x 1 mL 225 liquid
900 liquid
150 liquid
100 liquid
250 liquid
750 liquid
8R3400 Iron Chromazurol8R3401 Iron Chromazurol8R3402 Iron ChromazurolBR3O7 Iron Chromazurol
Colorimetric, Chromazurol S 6x25 mL
Colorimetric, Chromazurol S 2x50 mL
Colorimetric, Chromazurol S 2x125mL
Colorimetric, Chromazurol S 6x125mL
AilEqA Labordiagnostik GmbH.a,i
Page 2of7
Attachment to Letter of Authorization
E / f?tt N. Praduct name / hrameter R1 R2 Aux.Reag.
09.tL.2017
Vol. Format
BR-?+10 Iron Ferrozine
3R3410-S Iron Ferrozine
8R3411 Iron Ferrozine
3R1411-S Iron Ferrozine
BFG4LZ Iron Ferrozine
3R3412-S Iron Fdrrozine
8R3115 Iron Ferrozine
_ pEJ$I-9 _ I'gnjgrrozJry _BR349O IrON TIBC SL
8R3492 Iron TIBC SL
BR.}+99 IrOn TIBC
Colorimetric, Ferrozine@
Colorimetric, Ferrozine@
Colorimetric, Ferrozine@
Colorimetric, Ferrozine@
Colorimetric, Ferrozine@
Colorimetric, Ferrozine@
Colorimetric, Ferrozine@
Colorimetric, Ferrozine@
4x25mL
4x25mL
2x50mL
2x50mL
4x50mL
4x50mL
5x100mL
5x100mL
2 x12.5 mL
2 x 12.5 mL
1x25mL
1x25mL
2x25mL
2x25mL
1x125mL
lx3mL
1x3mL
1x5mL
725 liquid
125 liquid
125 liquid
r25 liquid
250 liquid
250 liquid
625 liquid
Total iron binding capacity
Total iron binding capacity
Total iron binding capacity
2x75 mL
1x75mL
1x50mL
_ _t 3si! _ _ 3f $_ _ _!2s_ _ _jjqsq1x120m1,2x7.5m1
1x50mL, 1x7.5mL
1x5g
ZXJUML 285 liquid
1x 30 mL 742.5 liouid
50 liqu./p.- -BR350O - faAut"
3R3500-S Lactate
8R3510 Lactate
3R3510-S Lactate
8R3700 Phosphorus UV
3R3700-S Phosphorus UV
3FG702 Phosphorus UV
3R3702-S Phosphorus UV
R3707 Phosphorus UV
3R3707-S Phogphorus 9!
Lactate Oxidase/Peroxidase 1x30mL
Lactate Oxidase/Peroxidase 1 x 30 mL
Lactate Oxidase/Peroxidase 2 x 30 ml
Lactate Oxidase/Peroxidase 2 x 30 ml
Ammonium molybdate 6 x 25 mL
Ammonium molybdate 6 x 25 mL
Ammonium molybdate
Ammonium molybdate
Ammonium molybdate 6 x 125 mL
Ammonium molybdate 6x125mL
1x20mL
1x20mL
2x20mL
2x20mL
1x3mL
1x5mL
50 liquid
50 liquid
100 liquid
100 liquid
2x125mL
2x125mL
1x3mL
lx5mL
-:t'IL-1x3mL
1x5mL
2x5mL
150 liquid
150 liquid
250 liquid
250 liquid
750 liquid
750 liquid
Urease/GLDH
Urease/GLDH
Urease/GLDH
Urease/GLDH
Urease/GLDH
Urease/GLDH
Urease/GLDH
4x25mL
4x25mL
4x50mL
4x50mL
5x100mL
5x100mL
4x250mL
2 x 12.5 mL
2 x 12.5 mL
2x25 mL
2x25mL
1x125mL
1x125mL
1x250mL
725 liquid
L25 liquid
250 liquid
250 liquid
625 liquid
625 liquid
1250 liquid
3R4000 Urea UV
3R4O00-S Urea UV
BR4O02 Urea UV
3R4O02-S Urea UV
BR4O06 Urea UV
3R4O0GS Urea UV
_ _8319L0_ _ !1e1u_v_3R,4200 Uric Acid
3R420GS Uric Acid
3R.4201 Uric Acid
3F4201-S Uric Acid
3R{203 Uric Acid
3F+203-S Uric Acid
3R4206 Uric Acid
3F42fS Uric Acid
3F3210 Uric Acid
3R{220 Uric Acid
Uricase/Peroxidase
Uricase/Peroxidase
Uricase/Peroxidase
Uricase/Peroxidase
Uricase/Peroxidase
Uricase/Peroxidase
Uricase/Peroxidase
Uricase/Peroxidase' '
Uricase/Peroxidase
Uricase/Peroxidase
6x25mL
6x25mL
3x50mL
3x50mL
6x50mL
6x50mL
6x100mL
6x100mL
4x250mL
4x500mL
1x3mL
1x3mL
1x5mL
2x5mL
150 liquid
150 liquid
150 liquid
150 liquid ,
300 liquid
300 liquid
600 liquid
600 liquid
1000 liquid
2000 liquid
3Fgtm Triglycerides
3F45FS Triglycerides
3F4il1 Triglycerides
S4501-S Triglycerides
3Fsi03 Triglycerides
F4irl3-S Tnglycerides
3F4ffi Tfulycerides94ffiS Tfulycerides3Fs5!.0 Tfulycerides3F4520 Triglycerides
,€:t10_ _ JrlglycgldgsS53m Albumin BCG
S5]+S Albumin BCG
3F5:O2 Albumin BCG
3F-if,32-S Albumin BCG
3F5:07 Albumin BCG
3F5$7-S Albumin BCG
_ _t€10_ _ Atlqmin_Fqc_ _*5:m Microprotein
S-<:SS Microprotein
S5102 Microprotein
95:12-S Microprotein
Enzymatic ESPAS
Enzymatic ESPAS
Enzymatic ESPAS
Enzymatic ESPAS
Enzymatic ESPAS
Enzymatic ESPAS
Enzymatic ESPAS
Enzymatic ESPAS
Enzymatic ESPAS
Enzymatic ESPAS
Enzymatic ESPAS
6x25mL
6x25mL
3x50mL
3x50mL
6x50mL
6x50mL
6x100mL
6x100mL
4x250mL
4x500mL
4 x 1000 mL
150 liquid
150 liquid
150 liquid
150 liquid
300 liquid
300 liquid
600 liquid
600 liquid
1000 liquid
2000 liquid
4000 liquid
1x3mL
1x3mL
1x5mL
2x5mL
Bromocresol green
Bromocresol green
Bromocresol green
Bromocresol green
Bromocresol green
Bromocresol green
Bromocresol green
6x25mL
6x25mL
2x125mL
2x125mL
6x125mL
6x125mL
4x250mL
1x3mL
1x5mL
3x5mL
150 liquid
150 liquid
250 liquid
250 liquid
750 liquid
750 liquid
1000 liquid
Pyrogallol red
Pyrogallol red
Pyrogallol red
Pyrogallol red
6x25mL
6x25mL
2x125mL
2x125mL
150 liquid
1 x 3 mL 150 liquid
250 liquid
-lt'rl---30---lq''d--
\t rEqA Labordiagnostik GmbH Page 3 of7
Attachment to Letter of Authorization 09.tI.2017
Vol. FormatF / fut rp. Muct name / hrameter3R5200 Total Protein
3i5200-S Total Protein3,R5202 Total Protein
3,i5202-S Total Protein3i5207 Total Protein
=;5207-5 Total Proteini;5210 Total Protein3R5220 Total Protein3fi5240 Total Protein
3R5101 Hemoglobin3F5103 Hemoglobin3F:5110 Hemoglobin3P5120 Hemoglobin
- =:SZOO
- ffJrogfobin nfc3P5201 Hemoglobin Alc
3F7lO0 Calcium OCPC
:F7:,FS Calcium OCPC
3F"102 Calcium OCPC
ll=rl'12-S Calcium OCPC
3Fa-',37 Calcium OCPC
lFT,l7-S Calcium OCPC
=F-::C Calcium Arsenazo IIIjFlll,tl-S Calcium Arsenazo III3l;-::2 Calcium Arsenazo III3F::2-S Calcium Arsenazo III
=F::7 Calcium Arsenazo III3F:-7-S Calcium Arsenazo III3F-::3 Calcium Arsenazo III
=trlfi€-S Chloride3F]3':2 Chloride
=tr.].:2-S Chloride3F-:7 Chloride
:F :'-r--5 sOOlUm
=F'5:1 Sodium
:F'730 Magnesium
=;-7aZ Magnesium
-.;?:7 Magnesium
Method
Biuret
Biuret
Biuret
Biuret
Biuret
Biuret
Biuret
Biuret
Biuret
Cyanomethemoglobin-
Cyanomethemoglobin
Cyanomethemoglobin
Cyanomethemoglobin
Latex agglutination
Latex agglutination
6x25mL
5x25mL
2x 725 mL
2x125mL
6x 125 mL
6x125mL
4x250mL
4x500mL
3x50mL
6x50mL
4x250mL
4x500mL
1x30mL
1x90mL
2x23 mL
1x95mL
1x10mL
1x30mL
1x3mL
1x5mL
3x5mL
150 liquid
150 liquid
250 liquid
250 liquid
750 liquid
750 liquid
1000 liquid
2000 liquid
- 3F5OO0 -nrr*i;-- -Edil.t-- 4 x 1000 mL 4000 liquid
4x6.5mL 4x2 ml 1 x 4 mL 34 oowder
85 powder
50 liquid
150 liquid
300 liquid
1000 liquid
2000 liquid
4000 liquid
-_3!q991__4ntolia__ _IEpg.! 1j:5i11__ 1j:2gl __ly,L_3R6100 Hemoglobin Cyanomethemogtobin 1 x 50 mL
:i5110_ _ fnoqlqb! _ _ -g1gpgtf1oglogil _?I0l tL
385205 Hemoqlobin Alc-Lyse rxsoomL500- - -llqud- -a? 42>v Hemoglodn AIc En4/matic lx 23 mt lx 1o mt,lx 14 mL 1x42.5 mL 47 loutd
il5251 Hemoglobin Alc Enzymatic
#.5252 Hemoglobin Alc Enzymatic
_ _i!o_2ls_ _ Inoglo_bU 4t_c_ _ _ :19ry!t _ _
3F6400 Glucose-6-PD Kinetic
2x10mL,2x14mL
1x40mL, 1x56mL
1x230mLLL _ _ _1l1j0i!1140J!
1 x 125 mL 40 liquid
720 liquid
2 x 42.5 mL 94 liquid
2 x 85 mL 191 liquid
2 x 272.5 mL 470 liquid
__3to_3q0__ fructo:annjpq _- _ _ Nitloglrtrlgzglign 10x11 ml 1xl20mL 1x2mL 110 pow./liquid
10x6mL 1x120mL 180 liquid/p.
1 x 100 mL 100 liouid
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_ _tlI_ _ 9alcl_un_o9,P_c_ 9-g1"l!l!.l9il _
150 liquid
1 x 3 mL 150 liquid
1x5mL
3x5mL
250 liquid
250 liquid
750 liquid
750 liquid
1000 liquid
150 liquid
150 liquid
250 liquid
250 liquid
750 liquid
750 liquid
4 x 250 mL 10OO liquid
O-Cresolphtalein
O-Cresolphtalein
O-Cresolphtalein
O-Cresolphtalein
O-Cresolphtalein
O-Cresolphtalein
3x25mL
3x25mL
1x125mL
1x125mL
3x125mL
3x125mL
ltsgT! _ _6x25mL
6x25mL
2x125mL
2x725 mL
6x125mL
6x125mL
3x25mL
3x25mL
1x125mL
1x125mL
3x125mL
3x125mL
2x250mL
jF.-3lrl Chloride r*.r,vlttl tni*v-"t"
Arsenazo IIIArsenazo IIIArsenazo IIIArsenazo IIIArsenazo IIIArsenazo IIIArsenazo III
Mercury (II) thiocyanate
Mercury (II) thiocyanate
Mercury (II) thiocyanate
Mercury (II) thiocyanate
Enzymatic
Enzymatic
Xylidyl blue
Xylidyl blue
Xylidyl blue
1x3mL
1x5mL
3x5mL
1x3mL
1x5mL
150 liquid
150 liquid
250 liquid
250 liquid
750 liquid
S-':7-S Chloride Mercury (II) thiocyanate
:tF- )-U 5mlum Enzymatic
6 x 125 mL 3 x 5 mL 750 liquid
6x25mL
6x25mL
2x125mL
2x125mL
6x125mL
2x20mL
2x20mL
2x40mL
2x20mL
2x20mL
4x20mL
6x25mL
2x125mL
6x125mL
4x250mL
1x20mL
1x20mL
1x40mL
1x10mL
1x10mL
2x10mL
_ P_T::i-9 _ Sq9rgn - !ryry$fFrSlt3 Potassium Enzymatic
jF --il0-S Potassium Enzymatic
=F "r5,i 1 Potassium Enzymatic
_f_'f--:-9_-?oja:sluln__ _Iryrylf_
I20 liquid
3Y0it _ _ 1i10ll _ _ 3y -L_ _ _L:o__ _llgd_ _
2x1mL
4x20ml 2x10ml 2x1ml 100 liquid
60 liquid
2 x 1 mL 60 liquid
50 liquid
50 liquid
100 liquid
150 liquid
250 liquid
750 liquid
1000 liquid__t?10__$logesig[_ _Iy]idyltl__
r.hf FlA Labordiagnostik GmbHa
Page 4 of7
Attachment to Letter of Authorization
G / hrt t o. Product name / ParameEr Metfiod Rl R2 Aux.Reag.
09.1L.20t7
8R7800-S Copper 3,5-di-Br-PAESA
3,5-di-Br-PAESA
4 x 22.5 mL 2x15mL
2 x 12.5 mL
2x25mL
1x3mL
lx5mL
1x5mL
1x5mL
t20
240
liquid
liquid$Zq0?-9 _ lojper 4x45mL 2x30ml1x3ml I25
1x5mL 250
BRZ)00-S Zinc8R7902-S Tinc
5-Br-PAPS
5-Br-PAPS
4x25mL
4x50mL
liquid
liquid
8R8501 Ethanol
8R8502 Ethanol
Endpoint
Endpoint
6x6.5mL
6x15mL
39
90
powder
powder
H&tprp8_sladuds_ __ts!5! 2_-0_1 _ !i gage_Sta$g En26r0-01 Cholesterol Standard (200 mg/dL)t251G14 Cholesterol Standard (200 mg/dL)
1x1mL 1 lpph.
_qE2_6l3j0J_llpleslelo!$e.!{ardjlo9.ndo_tl
1x5mL
14x5mL
9x3 mL
5
70
27
liquid
liquid
liquld
n280(F01 Creatinine Standard (2 mg/dl)n2800-14 Creatinine Standard (2 mg/dL)
_ts383_{p _ _c rgqli !.t Le _st3 dqrq lz 1n9ft r)R3100{1 Glucose Standard (100 mg/dl):R310G14 Glucose Standard (100 mg/dl)
1x5ml
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5
70
27
liquid
liquid
liquid
R3 103{9 Gl ucos_e Sta rylqq- LtLo Jng/d LJ
1x5ml
14x5ml
9x3 mL
5
70
27
liquid
liquid
liquid
n3200{1 HDL Cholesterol Standard (50 mg/dl)
_314q1_4_flD_L_clolegtgre!!te'!a1d_€o_n:g/a!)___
1x5ml
14x5ml
5
70
liquid
liquid
*,340041 Iron Standard (500 Ltgldl)n340G14 Iron Standard (500 pgldl)
_ttZ4!3jq9_ Irgn_Slaldjr! (sqoJg/dlj _ _ _R37m{1 Phosphorus Standard (5 mg/dl)R37m-14 Phosphorus Standard (5 mg/dl)
1x5ml
14x5ml
9x3mL
liquid
liquid
liquid
5
70
27
1x5ml
14x5ml
9x3mL
5
70
27
liquid
liquid
liquid_+3_43p _ lr1orylo1us 9tan! e4_(!. r/{tlR3!n0{1 Triglycerides Standard (200 mg/dl)*3qn-14 Triglycerides Standard (200 mg/dl)
_TLl{3_{9_Jr1glycSr1_desj!9$erq(zQo-11gldQt{103-09 Urea Standard (50 mg/dl):R11(b41 Urea Standard (50 mg/dl)sR41(F14 Urea_SJq1{a1dJs_o1npfi U _ _m-4fm{1 Uric Acid Standard (6 mg/dL)m.{ID14 Uric Acid Standard (6 mg/dl)
_qETE:q9_!'-!.c39td_sla1{-a1dls_n:gla!)_-ms0fi}or Albumin Standard (5 g/dl)gRStf,I)-I4 Albumin Standard (5 g/dl)
_qq[tQ _ Atlq_min _s!e 4e rq $ s& LJ
m5r02{1 Microprotein Standard (200 mg/dl)
_unsl{12_1_4_!(rgpgoleg_s$ldetq(zQo1rylo!)m5ltB{l Microprotein Standard (50 mg/dl)
_q$s_Et L4 _ rvl grg p_goleg_slgtdgrd [s Q f d{tlgnem{l Protein Standard (7 gldL)
mec4e Pretgil S_tgt laydJt_gld_Ll __UE99t91 _ Am m on ie ltsnlql{lo! uel{tlm7[m{1 Calcium Standard (10 mg/dL)mTUI)_r4 Calcium Standard (10 mg/dl)mTuB{e calciqm !ten!qq- Lto_Uq!{tLgnzllrcl Chloride Standard (100 mEq/L)
FfClF_|4 Chloride Standard (100 mEq/L)
mzm{e chlori{e slgldgrq (tQo_n1rg/D_ - _ _gR7{D{1 Magnesium Standard (2 mgldL)ER7{D14 Magnesium Standard (2 mg/dl)
BZ!F_{p _ -tt qgr ej i u q ft4 d ald_( z_ng!*)_
mtsOl{l EthanolStandard
1x5ml
14x5ml
9x3mL
liquid
liquid
liquid
5
70
27
9x3mL
1x5ml
14x5ml
1x5ml
14x5ml
lt tL_1x5ml
14x5ml
9x3 mL
1x5ml
14x5ml
27
5
___!0_5
70
___!_5
70
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liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
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5
70
liquid
liquid
1x5ml
14x5ml
5 liquid
!0_ _ _lqd_ _5 liquid
70 liquid
liquid
1x5ml
14x5ml
9x3mL
liquid
lx5ml14x5ml
:t'+__1x5ml
14x5ml
9x3mL
5
70
27
liquid
liquid
liquid
5
70
27
liquid
liquid
liquid
1x5ml
14x5mL
9x3 mL
5
70
27
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liquid
liquid
1x5mL 5 liquid
Bn!HNBR$IOEnsn20
AMP MultiCal
AMP MuItiCAI
AMP MultiCal
lyoph, calibration serum
lyoph. calibration serum
lyoph. calibration serum
5x5mL
1x5mL
20x5mL
5 lyoph.
100_ _.yg' _
BRSEO2 CK MB Calibrator _l'J$lx1mLBRIFO3 Bilirubin Cal. lyoph. calibrator
Page 5of7AIIES Labordiagnostik Gmb H
Attachment to Letter of Authorization
E/mm, Paratnebr
09.71.20L7
_ _889812 HDL Chot. Cal
_ _q89903 LDL Chol, CatiElttflo{t rr^-^--r I r
r^rr'rl 1 lyoph.
1xlml r ,..--L
Aux.Reag. Vol. Format1x1mL
- -F9-813- - flnoglo-b4 Al-c-cel. _ .!yopr'. catibration serum
_ BR9_8L4_ _ lrgcloraln4re C;t. - - r-v"pnlJiu-oiloi-#rrn- -ataarorr r, --,--:-: i;-
_ _R9_8 L5_ _ I gqo gl o_b I Stg . _ _ _ _ _ _ .!yo I h. ca r i u rati oi' s.-e nir-_ _Bs_sl8_ _ _0-IfdtorylrlyEl._sq_ - -rt*0.J
ttat^6{A ^ |
1 tyoph.
4x0.5mL 2 tyoph.1x2mL -'--;^A--_'^:'".__ 2 lyoph,
1x2mL 2 tyoph.
_ _BRql!g_ _ Adenosine Deaminase Cal. -
::_=
L tfvvtt,
1x3mL -"--;:,--__,:1r_-__ 3 tiquid
1 liquid
@fiols- -gn99OO- - AMP M"tm'ol i - - - - - - -V"prL--d"GJr-. - - - - - loi s-,i - - -8f,9950 AMP MultiTrol I ryopn. contror serum 1 x s m! st' ll'ph.
m9955 AMp MultiTrol I Dopn, conror serum 5 x s DL s lvoph
41901 AMp MultiTrol II voph. controtserum $xs mL 2s lloph.
n9951 AMp Multilrol II ryopn. contror serum 1 x 5 m! s0 it.ph.
n9956 AMp MuttiTrol II ryoph. controt s€rum s x 5 mr s hopl'.
25 tyoph.lxsmL 1x5mr 10 Doph.
--=,=:-- i,l5iYgsr+yldle_rgn!._ _ ggplSrgA _ _ __ _ __ _r:sJl_ _:!5ra --t;,1-- - --- -- --:o- --*-*- -
z tiquid
$gift_gr!97!1ole!nsn54OO- - nntiltr"pt"fy". O - LT
- - - ;t* tr[ilir'*t-rv
1x1mL
m9|(fs Antistreptolysin O- LT9R5401 Antistreptolysin O- LT
UR54f0 C-Reactive protein - LTm5|tGs C-Reactive protein - LTm5rlf C-Reactive protein - LT
_ re!]-! _ C-Reactive protein - LT
mSrsGS Microalbumin - LTm5{5f Microalbumin - LT
n9+70 Ferritin - LTRs4rc-S Ferritin - LTn9{71 Ferritin - LT
latex turbidimetry
latex turbidimetry
1x40mL
1x40mL
2x40mL
2x5mL
2x5mL
4x5mL
4x5mL
1xlmL
1x1mL
liquid
liquid
liquid
qn
50
100_ ryfl-! _ lltiqtrep_to-lygilg -_LJJ - Ll latex trturbidimetry 2x40 mL 100 liquid
latex turbidimetry
latex turbidimetry
latex turbidimetry
latex turbidimetry
1x40ml 2x5ml1x40ml 2x5ml2x40mL 4x5mL2x40mL 4x5ml1x40ml 2x5ml1x40ml 2x5ml2x40ml 4x5ml2x40mL 4x5ml
50 liquid
1 x 1 mL 50 liquid
100 tiquid
1x1mLCRs{20 - c n"u.tiue-proGin ;i LT - Iri;.;;,il;*tR9{2Ds c-Reactive Protein us - LT ratex turbidimetryffi$a21 C-Reactive protein us - LT tatex turbidimetry
_ re?1.! _ _C-Bga$ive P1olein us - LT tatex turbidimetryIng4O- - tipop.Gn [; - gt - Gt.* trroioil:;;
il5.40'S Lipoprotein (a) - LTms+tl Lipoprotein (a) - LT
_ ry!l-! _ _LiEoprgtgilQ)_-_t_r_ _ tatex turbidilatex turbidimetry.--L'__m9r50 Microalbumin - LT
liquid
1x40 mL
1x40mL
2 x,10 mL
2x40 mL
2x5mL
2x5mL
4x5mL
4x5mL
1x1mL
-1grL_ _
1xlmL
1x1mL
50
50
100
100
liquid
liquid
liquid
liquid
latex turbidimetry
latex turbidimetry
50
50
100
100
liquid
liquid
liquid
liquidlatex turbidimetry
latex turbidimetry
latex turbidimetry
1x40mL
1x40 mL
2x40 mL
2x40mL
2x5mL
4x5mL
4x5mL
2x5mL
1x1mL
1 x 1 mL 100 liquid
50 tiquid
1 x 1 mL 50 tiquid
100 tiquid
lx1mL
s0
50
100
liquid
liquid
liquid
n5a6GS Rheumatoid Factor - LT tatexturbidimetrymg6f Rheumatoid Factor - LT tatex turbidimetry
_ ryf1-9 _ !.hegqplo(fqgtpr - LT tarex rurbidimerry
1x40mL
1x40mL
2x40mL
2x40mL
2x5mL
2x5mL
4x5mL
1t s_2x5mL
2x5mL
4x5mL
liquidlatex turbidimetry
latex turbidimetry
latex turbidimetry
1x40mL
1x40mL
2x40mLlx1mL
50
50
100
100
liquid
liquid
liquid
liquid_ 85?1-5 _ ferritin - LT tatex turbidimetry- c-nJaaive-proGin --;r;;a;,ir-"* 2x40ml 4x5ml txlml
2x25mL ;; *-Rt/3(FS C-Reactive protein rmmunoturbidimetryBR.5Z|1 C-Reactive Protern rmmunoturbidimetry
_ SZ31-! _ !-3g$ive Proteln rmmunoturbidimetry
2x25mL
4x25mL
4x25mL
1x5mL
2x5mL
2x5mL
1x1mL
1x1mL
55
55
110
liquid
liquid
liquid
110 liquid
A.UE A Labordiagnostik GmbHPage 6of7
/
Attadrrnent to Letter of Authorization 09.11.2017
GlEtn ffitdrpnel hnn# Aux.R€ag. Vol. Formatnsno IgA Antiserum lrnmunoturddtmetry 2 x 25 mL 50 |hddln5/&5 IgA Antiserum xnmunoturudtmew 2 x 2s mL 1 x I mL fl) rbutdnSnl IgA Anuserum Immundurbidtmetsy 4 ,( 25 mL uo qlid
ry19-l944lti:9!u0-------lryySgggaqg-----jlrsj! rxlml 100 rhurdRtD IgG Antls€rum rmmunohlrbtdttr|etry zr-zslni------ ----;;-T;;;--I5 X>S IgG Antlserum lrnmunoturbidtmeuy 2xzsml 1xlml 50 thutdnS rl IgG Antiserum hmunoturbtdtmeby 4 x 25 mL ro0 qutdg_19-!g-G4ltEefugr-------Imgui$grgtq-----lfs-l't!__ rxrml r0o r,qddX5&0 IgM Antlserum lnmunohrrbtdtmcrry - z,-zs-ri----- ------f --|;rd--nSfXlS IgM Anuserum ImmunotubtdtmeEy zx8 nL I x 1 mr s0 thddn5$1 IgM Antiserum lrnmunoturbidjmetry 4 x zs mL r00 thutd
-=P-19-g!-4!ti!elurt-------lrygg4igtrq----_jlar! lxrmr n rqrdn58(tr Microalbumin lfiu"drd;n-er.i-----;;i'i-----i-i,-L------------;i-t;-*--II&IIS Mictoalbumln rnmunoturbdimetry zx25ml lrsml lxrml s5 tbutdI$3f Mkmalbumln lrnmunot.rrbidtnEby 4 x 25 mL 2 x 5 |hr lu &dd
-$J-9--!tEeelur'1'L-------!lg,{'gggtq-----l!sr"! 2x5mr. rxrml 1r0 rhurdI5E50 Rheumabld hctor rrnmunoturbidimeby z "-xl"i
--- -- i"!;i- - - -- --- -- - - a-- i1qrt -nslsGs Rheumatoid Ecbr Immunotubrdrmeby 2 x zs mL 2 x s mL lx t mL 60 rhrrd!5851 Rheumabid Ecbr lrnmunoturHdtmetry . x 25 mL 4 r 5 mL rN tqutd
_FF!-g _ B[eg]lap!_dFlEr_ _ _ _ _ ]mggg4ig,l!E_ _ _ _ _ lL5_'! _ _ _ _ _ 1tIr_ _ _ _ _ _ -1!,i 120 rh,rd
-futwia-sha@Hs--__rgroa As-L(otsbnoaru ------d-------- --;;;r----- ---r---r6ia--I t2 ASL(O) Standard hEh IxI mL r |hurd
--E!C,6---S-!t9)gta.J'q.ard--- set 4x1ml 4 ,qudIerir enpsanaEra--------d---- ------i;;i- --i--.;A--
I9{f2 CRP Standard h6h 11 1 mr I ,ouuI9fl3 CRP Standard - superhtgh lx1ml r Rrd
--E-5- -99_-sF_qagr!---- set sxlmL 5 qddIOr2T cRpGsta;Ard------"n i""-liul"- ------i;;- --;--;;----E?5--- - $BP- --,ls-E!qatd- - - set 4xr nL . rqrd--q!L_ Ielil ste"q"Id;: _- _::: $r_ _::::::::::_ _:: _ _ _ _::,,.r il:: _:: - - -;- -,'#- -
19151 Mkroalbumin Standard row ------i;;r- --r--'rna--E 5A Microalbumln Standard hioh rxlml r qld
-E-r$-- - !_Epe!ogtli!.s-tal'{a.d set sxrm! 5 q.,----ti5a nrJunoafu--------t*-------" -------------i"i;i --;--fffi--
!|51 RF Standad hish ' lx 1 mL r |huklGl RF Standard super htgh lx I m! t hutd
--!=.-lS---S-1b.I'g?4=-.--. set 5xrml s qrd
---m--Fe-lritin-Sano-aro-------ro* ------- ---i;*-------------;--fr;-Gn Fenitin Standard hish I x 1 mL t rqud
-!S_-- trltlS!.geltq€fd- - - set 5xl mL s
'odd--c{5 Froe-ins-anoara------frcT---- ------i;;i- -i--]il;--
-lEfr--!'ptsEqqdard--- s€t -_______g,,lrr_____________5__-jlcgd__
*MinControls---rot rsLeoldontroi- - - lrlml 1 |hutdre ASL(o) control txsmL s |h,td
-iiirr--ifr-o:ntror--------;;li*--------- i;;.------------,--r;il--Gl5 CRP Contsol uttra tow 1 x s mL s qjdIiill CRP Control brv lx 1 rnl r
'odoGilS CRP Control .bw rxsm! 5 rourdItr31 CRP Control hEh r x I nL r qdd
---gS-- qsr lx5mL s qdd-Ea ---------;-;:--------- 2 thtlHGSI C.ontrol -------;;;r- --r--',ura-----SEf--!f,petug'Ii!.Q!tpl---- lxsml 5 rqurdF51 RF Conbot - - i,'i;.- - - - - - - - - - - - -r- - ,* -
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AIEDA tabordiagnostik GmbH Page 7 of7
B,R.Zl:. 2923117lnp
GemiiB S 79 (2) der Notariatsordnung bestiitige ich die Echtheit der Firmazeichnung der
Frau Christine Magdalena H e rf o rt, geboren am 15.06.1967 (frinfzehnten Juni neun-
zehnhundertsiebenundsechzig), Lindenweg 9, A-8046 Graz als Geschiiftsftlhrerin der
AMEDA Labordiagnostik GmbH nlit dem Sitz in Graz und der Geschdftsanschrift
Krenngasse 12, 8010 Graz.
Gleichzeitig bestitige ich gemaB S 89a der Notariatsordnung auf Grund der heute im
elektronischen Weg vorgenommenen Einsicht in das Firmenbuch, dass Frau Christine
Magdalena Herfort berechtigt ist, frir die unter FN 339703p eingetragene AMEDA Labord-
iagnostik GmbH selbstdndig rechtsverbindlich zu zeichnen.
Premstdtten, am 09. 1 1 .201 7 (neunten November zweitausendsiebzehn).
Ceftification Reqister No: 292311 7/mp
I herewith certify the authenticity and genuineness of the foregoing signature of Christine
MagdalenaHerfort,bornonJunel5th, 1967,inLindenweg9,4-3046Stattegg,acting
as general manager in the name and on behalf of AMEDA Labordiagnostik GmbH with
principal place of business at Krenngasse 12, 4-8010 Graz,-
After today's duly inspection of the Commercial Register kept by electronic data pro-
cessing I herewith certify pursuant to Section 89 a Notaries Act that Christine Magdalena
H e r f o r t is acting in the name of the AMEDA Labordiagnostik GmbH as above men-
tioned and that she is duly authorized to sign as general manager, in the name and on
behalf of AMEDA Labordiagnostik GmbH with its corporate seat in Graz, registered with
the Commercial Register ("Firmenbuch") of the Commercial Couft in Graz under Court
File Number FN 339703 p.'--r'Given at Premstdtten, this November 09th, 2017.---------
6,.1 I
,i
f;
'cher Nctar
L:
LANDESGERIcHT TUn zRS GRAzDER PRASIDENT
GZ: 3 Jv 30761172
{Bitt* m allen Lingalsuxt arzVfiirent
Die Echtheit der Unterschrift des Mag. Robert Esposito, offenlicher Notar inPremstdtten, sowie des beigesetzten Siegels wird hiermit bestaitigt.
FUr den Prds
U
Graz, 09llll20l7 27t
Gebuhr in Hdhe von EUR 14,40 entrichtet.
Die Echtheit der Unterschrift des (der)
UreuIa BTERBACTIERLandesgerichf frr Zivilrechtssachen Grtz
sowie des vorliegenden Amtssiegels wird bestiitigt.
KLAUS Prot.Nr.
Verwaltungsabgabe € 3,20 entrichtetBeglaubigungsgebtihr € | 4,30 entrichtet
rJ
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(,')
serte I Yon I
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