‘CUC LIEN BANG VE THUOC VA CAC SAN PHAM Y 18 (FAMBP) CHUNG NHAN LUU HANH TY DO. The yD) si chin in: 0002204-09-18 Qa ult a (ing on: ‘Qube gia np Kiya cu): VigtNam MYC DO NGUOL NOP DON XIN CAP GIAY CHUNG NHAN DIEN 1a vi dag sin phim: ‘ii iy, vlog cu lp thn bo Phin chin hind eyp X-qung pin on in Phin him theo Ch SDIEC: C—O a GIB 1.2, Tha phn oem tn i 8 dish Lagu (theo fog it i: Ci hi phn in i zg 1a Wg dh nti deed dlc home ee: ‘Oto CP-GU; Oro CP-GU pin X quang ph quay cl mia xa, den, dong, Pin trng inh fn en, duped ki dyng ron X quang ni chun "Onto CP-GU! M Ortho CP-AU M 1a pin X quan ph i hy lm maa xan, Be 6 ao, tone hin rang bi cao de tit. rng ong X quar 6 eng. =CEA OGX: CEA OGX Ia phi X quang ps gu iia mau san ft dao, cuong pin ‘rung inh dines, dupe tit i dg rong X quang ni chung 13 Sin pilin ha eed niin phe Wing EC DB? — Niu ci et ob guint 8 no? 14, Sin pmo dge elt Kh? Néued, i dupe elt nto? 1.5, Sin pc cha eht ping x Rong? [Néu,dngv ping obo mhigu Beegerel? 1.6, Sin pi yee php du rah ng ir yng & qe gia xt Ka Rag? 1.7. Sin pln ayo te yc mt nt rg mK Kg? 1, Sin pn su do ung nin hig CE theo Ci tj 9942 EC ag? 2 Tn in en quan dn a sin 2.1, Nha sin sto dish aha ea Ch th 93427 nv diac ‘AGEA NV, Sepesirnt 27,260 Morte, 22, Nga nip don sin ip ching ni ‘Win Ciomns, AGFA NV, Sees 77 7680 Motel, BT 23, Ten vib Ca quan tig Wo (ou 8) Ine Senko AB, S5TD.OUIT 2.4, Nhs lt ge ea hn in hie chub 0 9000/ EN 13485 cus? ‘Nhu hy nn chi dco ep ing da: Ite Ceriiation AB Néu hd, va ng hh osPHAN DANH CHO Co QUAN QUAN LY ‘Tile byt duoe me ty dpe cho dp tng ce guy din ig hi ea Cit dng 8 S3/4EEC v4 6M dave dara th tame 6 age wt Kh iain erg china ‘COCTIEN BANG VE THUOC VA CACSANPHHTY TE EUROSTATION It, Vise orp 40 but 0, 1060 BRUSSELS (3) Di thal ah #503 3440.0. Sz karasa Temata eer aly Ips Snead agg (BH kj vi dng du) DAL SU QUAN NUGC CHXHCN VIRT NAM TALBL age ch St: Brue-xen CHUNG NHAN/ HOP PHAP HOA LANH SY |. Que gia: VIRT NAM 5, vi hie dani: Vign ee Hanh sy 4, vlcon du cia: BO Ngo giao Virong Que BE 7. Co quan elp: Ba sit quin nadie CHXHCN Vigt Nam 91 BE 8. Sb: B72018-CNLSIIPHLS, ily na ia my Martine ky hing sn! hop phi hin fin se 6. Neds 18 £09 /2018 TL Dats Blt ba (013 vd di) Nguyén Th Bich Noe fsf pESE teeCHING NHAN BAN DICH Cong ty TNHH Dj thu chuyen ngigp AZ “enn ring dog VU Van Hid, CAND sh 031758365, lp ngiy 18/11/2008, tl Cag an Hal Ping I bign dich ‘ven eta cing ty TNHH Dich tuft huyén nghigp AZ ch ein xe vn bin wnt ing An sang ting Viet ‘hed chi xe nn kd theo Nay OF tig 1 in 2019 Newer pic CONG TY PNHE DICH THUAT ‘CHUYEN NGHIGP A7. Obi hr hin) BSc jee BR reFEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS (FAMHP) FREE SALE CERTIFICATE medical devices (MD) ting eri) ety: al aouane Importing (requesting) county: ac SECTION TO BE COMPLETED 8} 1, Name and form of product: fn dass HD ease rove erate [ortho chromate Fim for Goraohy {LL Grouping aceardng to Diretne 95/A2/EC: CT Cie/im @la Clb Cl 1.2 Qualative and quantitative cmposton or description (according tothe type ofthe device): ‘The qualtative and quantitate eampestans are ndspensnbl the device Is nthe form of oliten, eum ae F Ortho CP-GU: Ortho GPGU ie aren senlive universal Xray fim, high apeed, med to High conta, laesigned for use n genera ade | ortho ce-ci Monto CP-GU M = areen sensitive universal X-ray flim, highspeed, medium to high contrast, designed fo sen general adlogy. |'ceA OGx: ceA Ocx sa green senlive universal Xa fl, high spd, mecurn to high contrast, designed locus n general acolo. 4.3 Doosthe product contin nina ibstoneas? iw] 110, bch ana satstanee[___ 1.4. bots he product conta medal sbetancee? fo Ives, wh medina sibtanas 4.5 Does te proc contaln redatve substances? ye, whieh dsotpe ad how mh Bevere[ 1.6. Is this product authorized to be placed on the market for use In the exporting country? fros 4.715 sprout acy en themaret inthe exotng our? fe__] oes the exported product cary the CE mark according to Diectiva 93/42/EC? [res 2. Information regarding the manufacturer: 2.4, Manufecturr(accorlg ta the definition of Directive 95/4Z/EC): name and addres [aceaw sepesuont 27,20 Mose ebm 2.2 Applian rr oxo: [im ones ASEAN, Sepesan 27, 240 Horse Balun 2.3. Name end number ofthe Notfed Body (f applcable):nteek Senko AB, Wdnanber D419] 2.4. Has the manufacturer been ctf to ben compllance with ISO 9000/ EN 13485 standards? es yes state the name ofthe orynlsation that delivered the cartieatefintertek Corieation AB 1 no, please explainRESERVED FOR THE ADMINISTRATION Tho medical davies as described above i presumed to moot tho applicable provisions of Council Directive {83/42/EEC and ean be placed on the marke inthe exporting county. pres a cn oy EDERAL AGENCY FOR PEDTCNES 7m Jevaosration i, view rtapen 40 bus 40,1080 HUSSELS (BELGIUM) [stephen +22 5200.00 afmps f= fagg SS LUBGALISATIE - LEGALISATION- LEGALISATION aglimndennae ie pert oi& censure en “ea ‘wernt 7 erm nty paid in ong ae ig go tang. rie ig i toca cay aye lp oso creN VATA HL Sy