(CYC LIEN BANG VE-THUGC VA CAC SAN PHAM ¥ TE (FAME
CHUNG NHAN LUU HANH TY DO
“Tiley 4D)
Sb ching nis 00001904-09-18
(hfe oa wa kk ein B
(Qube sa np Ku (y8u clu). VietNam
MYC DO NGUOI NOP DON XIN CAP GIAY CHUNG NHAN BIEN
1. Tén vi dang sin phiim:
Dai voi thiét bj y té logi |, vui Bing cung ep s6 thong bio
1.2. Than phiin boge mo t& dirh tinh va dnb Lugng (theo Hogi thige bi):
err eerpray
Nee eee et shige abtoniarhoetales
edna mats
1.5, Sin pti eb chine chlicbnpudn fe wrdong vatRNing? SSC
bud, Welt eénguln ge tng vat no?
14, Sin po chia due hit King? ht
ud, de cit no?
1.5, Sin phim eS chin chit ping xp King? Kids
[Nl e, dng v hg x9 no bao nhieu Beequre!?
1.6, Sin py de php dm rath rng 6 ae dng gue aK King?
17. Sin pny tye se} mat wnt ud 8 mde xa Ki ng?
18. Sin plans 8 mang nha gu CE theo Ci th 942/ EC Kn?
Bep
2g tn én quan no sin a
21, Nh sins tho dn nine Chi th 934D/EC tn vi ei
[AGFA NY, Sepesr 27, 260 Mere 1
22 Na fp dan si ching
Trea Goo Magee Gey Kear]
Tinhuaddap cae anata DOSEN Dasa? ob
evanay ner bcucdreney ng oe nea Cen 38PHAN DANH CHO Co-QUAN QUAN LY
‘Thi bi yt age md th nd de ch ip dg ee guy dink bi in a Ch i gS
S3/IEEC viet due dart rgd me ult ku,
‘jaca co gan chingat:— | CUC LIEN BANG VE THUDC VK CACSAN PARTY TE
HUROSTATION Vier Hopi 10 us 0, 1060 BRUSSELS (8)
Dia hl ah #323 38.0.0
[Np TE Tea de yaa
(ora afmps Srl
lagg (149 vn
&
DAL SU QUAN NUGC CHXHCN VIRT NAM TALBL
CHUNG NHAN/ HOP PHAP HOA LANH SU
|. Qube gla: VIET NAM
‘iy ara Tiga iy
2. do Ong (Ba): Veldeman Martine ky
53 vi eit dan: Vign ec limb sp
4 vtcon du eli: BG Ngoai giao Vuong Quée Bi
uae ting nod ngp php hia inh sy
S.tgsBruesxen 6, Nay: 24/09/2018
4. Cy quan cip: Dai si quan nude CHXHCN Vigt Nam (91 Bi
8, Sh: 975/2018-CNLS/HPHLS,
PL. Dai si
nit
aby
Nay Th Bich Ngo
aa the oeCHING NHAN BAN DICH
‘Cg ty TNH Dieh that chuyén nghigp AZ.
Xée nh rng ng Vi Vin Hin, CMND s5: 031758365, ep ney 18/1/2008, 9 Cégan Hi Png bi de
‘ian eta ng ty TNHH Dh haf cya nghigp AZ dh chink xe vin bin nt ing An ang tig Vigt
‘bed ct ky xe aga kd theo.
Nady OF cing 0 nn 2019
Never pic. (CONG TY THM DICH THUAT
‘CHUYEN NGHTEP AZ.
(i hr ha)
‘Va Vin HidaFEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS (FAMHP)
FREE SALE CERTIFICATE
medical devices (MD)
SE me ronisoow 1a |
J
importing (requesting) country eam
41. Name and form of products
tercuat Wo, esa ie
fray am process ama gic (tation ner BEICAO/I 700% 20005 CL)
‘1.4, Grouping according Wo Directive 93/42/EC: @ I Cisfim Cla CH CM
1.2, qualtative and quatativeconposton or design (acrdng to tha type ofthe dev)
‘ent nd onto onan oe nab he eh theo on,
[.E0,s, De. Tires part ecolpatayopiised devlaper for medal in based on Wd concenates, |
fut or xen medical rect
['0.. Fe: Two-par,ecloial optised developer fr mel ln based on laud concctrates, uted
for usin ds! processors
section To BE oon AY THE APPLICANT OF THE CERTIFICATE
4.3, Does the product contain aninal substances? fre
1 yes, whch animal substance
44.4, Does the product contain meelinalsubstancas? fro
1 yes, which medlinat substance?
1.5. Dos the product conta redecivecubetancae?
yes wk lope an om ny ecg >
1.6 ether thre tte placed onthe markt rset eoring com? fs]
1.7. es prota on ha markt eee cami? fee]
Does the exported product cary the CE mark according to Directive 93/42/62 fs) |
2. Information regarding the manufacturer: |
2.4, Manufacturer (according to te defriton of Dcective 93/42/EC): name and adress:
1 Septet, 3640 ont Baan
2.2 Applcant for certiest
[rimconens AGrAWSepenan Owonsmgum ———~S~*~*~“‘“~*“*~“~*~*~S~S*d
2.3, Name and number ofthe Notited Body (i applieable) [WA for dass Tpredut |
2.4 Has the manufacturer been cid tobe in compliance with 150 900/ EN 13485 standards? res
yes state the name of the organisation that delvored the create inten Cerication Ab
1, pea
Ee-y
ehRESERVED FOR THE ADMINISTRATION
|
“The medical daveo as described above is prosumod to meet the applicable provisions of Council Diectve
{82/42/EEC and ean be placed onthe market in the exporting county.
r DEAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS
a et Mme |
Pg
B avz19470 8 o0219670
UIGALISATIE-LDGALASATION-1EGALISATION
Pil ate we aang —— ‘
See 1
mtotaineeae Taek
fccntepna a X
[$< itteee
el tince niteexten
sau
none xupaor rea ge
ute ‘eras
si da. acta
eine ome
Siti
oni iii
sng sen cys ra
sRqunety as cms enerNAMTA! AL
aon rt en ya
Ey