BAN DICH TRANS) ye iN pan VETHUGC VA CACSAN AM Y TEAM TION CHUNG NHAN LUU HANH TY DO. “Thi by (MD) behing abo 0003904-09.18 (Qabegia lt hig BL Qe gia np ka (yc) VietNam UC DO NGUOL NOP DON XIN CAP GIAY CHUNG NHAN DIN 1.Toa vi dng si phi i iy, ullbngcone po ting oo Phim chp X qusng aba Khoo fi miéng TL. Phin him tho CHI] O3ADIEC: CTCF —— el CTS 12. Tho pin het ith 8 nf mg (he lo eb (ic hin en dn th tic Hg hn nba i dong em ele ~ CEADENTDI:CEADENT Ti phi nfa Khoa ining de dong Ki i ie i i X quan tre tif 13. Sin pine cia ce lic ag le i va vt Ea? Nuc, eb gun ae ng vt ni? 1A, Sin pn ob cha dct King? ‘Nu I de cht ni? 15. Sin pine cha elt png 9 ng? ‘Nuc, dv hing 9 nov bo nigu Bede? 16, Sin pm myo depp dn ah rg ir yg gd gia xu ku King? Cb 1. Si phy hy nt nt ng ew Ka Kg? 18, Sin psn su uc mang nh ga CE theo Chit 93421 C King? PRE ee 2g tn Bn quan nn sin 2.1, Naa ins tho di nia ea Chi th 93420 nv nei [AGFA NV, Septsiaat 7,268 Moris, BI 722. Nau np dan xinelp ching hi [wince AGFA Nv i AGFA NY, Sepesma77.260 New 2 Ten vb Co gun tng to (8) nek Senko AB.S6 TD OHS 2.1 Nh cd nut dx ge chig nin an thee i ck SC SONNE URS ch? Nu day nu en he ang cp ching he: Ineek Certain AB ‘Nhung, vu King tehPHAN DANH CHO co QU. IAN QUAN LY ‘hid yt due 6 hr dy deco dp dmg oe gy in hig bi ds C1 Hoi gd 932088 vied thé due dua th vg te ti, ‘Bi i cn co qu cng ni ‘GUC LIEN BANG VE THIUOCVK CACSAN PHAW YT EUROSTATION I, Vir Hopi 40 bs 40, 1060 BRUSSELS (Bi) ign #523 $2840.00 RF nT “Tenn dey ate Peon Xavier De Caper (Dr ding dh) ‘itm aia hk (Diy viding ts) 1. Qu6e gas VIET NAM 5. vi che daa: Vig eh 7. Co quan cp: Dai sig AL St/ QUAN NUOC CHXHN VIET NAM TA Bi CHUNG NHAN/HOP PHAP HOA LANH SU 2. do Ong (Ba): Veldeman Martine ky 4. vacon dl ci: BG Ngo giao Vuemg Que BE dye ching nah php ha a se St: Bewesten 6, Nedy: 24/09/2018 8. Sb: 9782018.CNLS/HPHLS. iy aa gu niy hie Hin ruin nic CHXHN Vigt Nam (1B ‘TL. Dai sie 1 hth ba (D5 kg va ding du) Navyda Th leh Ngge WA ss-CHUNG NHAN BAN DICH (Cong ty TNH Dh that huyén msigp AZ xe nn ring bog Va Van Hidn, CLIND 55 031758365, lp ely 18/11/2006, oi Cng an i Phong ign dich ‘van ota cing ty TNHE Dich tht dyn nghigy AZ dich chinh xe vin bin wnt ig A sang td Vit ‘hed chit xe nak theo, Ny 04 ting 1 nin 2019 Newer vice. CONG TY TNHH DICH-THUAT ‘CHUYEN NGHIEP AZ. eh hin)FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS (FAMHP) FREE SALE CERTIFICATE medical devices (MD) ating Cetin) ety elm eae Importing (requesting) county {ism —_ ‘SECTION TO BE COMPLETED BY THE APPLICANT OF THE CERTIFICATE 1, Name and form of prod for ease 1 0, pease prvi tha nt ARIE CL Cifim 6a ClO 4.2. Qualative ana “amposion or desertion (according tothe type ofthe device): The quatative and quanetive eampositons are nalspensable Ifthe devie fs Inthe form of @sauton, ream 90 [CEADENT DI: CEADENT DI pn intra-oral dental lm for use n deh Xray exposure, 1.3. Does the product contin ane substancas? 1 yes, whlch anol substance 1.4 Doos the product contain medial substances? fe ye whieh medal abstanoe{—— 4.5, 00th roduc conta ontv substance? BS es) 11 yes, which radoistope and how much Becquereh[ 4.6.15 this product authorized tobe placed on the matket for use nthe expartng country? [Yes 4.7. Is this product aaually onthe market inthe exporting country? (S 4.8. Does the exported product eany the CE mark cording to Directive 92/42/EC? [res 2. Information regarding the manufacturer: 2.1, Manufacture (aeorlng tothe defton of Directive 93/42/EC): name and adres [nceawSeptestan 27,20 Moran abr 2.3. Applicant for ceria: [in Goren AGFA Sept 7 20 Mel eg 2.3. Name end mune ofthe Nid ody (epee nek Senko AB, mamber O41 2.4. os the manuacirer bon cried to be complance wt 150 S000 13485 standais?fes | Ir yes tate ne nan othe gato a evered he cerneaenak artncaion AB] re, lease exa: [__ —_] PerggararnRESERVED FOR THE ADMINISTRATION The modical device as described above is presumed to meet tho applicable provisions of Council Diractive 93142/EEC and can be placed or the market nt [eopone ne: 432 7500000 : afmps fF faqg B 00219675 1B onei9475atraiermecaaae, ‘og us ule won Any ate mrt paca 2a tee sort iii sce cy si 208 do ISO CINEN ECFA TA Xhmwn-cosnns hr te ate ‘arate