(MD \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ '\ \ \ \ \ \ \ \ \ \ \ br>--\ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ ;fi| Graz- November 9th. 2O1Z LETTER OF AUTHORIZATION crAY uy euyEN We, AMEDA Labordiagnostik GmbH, having facilities at Krenngasse 12, g010 Graz, Austria, as the legal manufacturer (product owner) of medical devices as listed below hereby authorize ANH QUAN TECHNOLOGY & TRADING CO., LTD of No. 74, Alley: 69A/ 48, Hoang Van Thai Street, Thanh Xuan District, Ha Noi, Vietnam, to circulate 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 uy quyEn 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 and quality 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 lUdng vir bao dam cdc diEu ki€n vE biio hinh, b6o tri, bao dr.fdng vd cung c6'p v6t tr/, phq ki6n thay 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 GmbH Krenngasse 12,8010 Graz / Austria * Phone +43-316-69 80 69 * Fax +49-316-69 80 69 12 * www.amp-diagnostics.com E-mail: [email protected]* Registration no.: FN 339703p at Commercial Court Graz * VAT No.: niUOSggOgO+
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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.
G / hrt t o. Product name / ParameEr Metfiod Rl R2 Aux.Reag.
09.1L.20t7
8R7800-S Copper 3,5-di-Br-PAESA
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240
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4x25mL
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8R8502 Ethanol
Endpoint
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39
90
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_qETE:q9_!'-!.c39td_sla1{-a1dls_n:gla!)_-ms0fi}or Albumin Standard (5 g/dl)gRStf,I)-I4 Albumin Standard (5 g/dl)
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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