E L E K T R O T E C H N I C K Y Z K U S E B N I U S T A V

ELECTROTECHNICAL TESTING INSTİTUTE - CZECH REPUBLIC

ELEKTROTECHN1SCHE PRÜFANSTALT

-

TSCHECfflSCHE REPUBLIK

MSTITUT

ELECTRÛTECHNIQUE D'ESSAIS - REPUBLIQUE TCHEQUE

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Po d

lisem 129,171

02 Praha 8 - Troja

CE - CE RTIFICA TE

of production quality assurance

No.: MED 060019

The Electrotechnical

Testing Institute, Notif ıed Body No. 1014, has decided that Quality System applied by

manufacturer HİJYEN GIDA KİMYA İLAÇ SANAYİ VE TİCARET LTD. ŞTİ.

Cumhuriyet Mah. Atatürk Bulvarı Kalite Konut Apt.

No: 19 D:6

B.Çekmece,

İSTANBUL, Turkey

fo r manufacture and final inspection of medical

devices

Manufacturing and

sales

of

medical disinfectants

complies with

provisions of Annex V

section

3 of th e

Council

Directive 93/42/EEC inci. amendments.

This decision is based on the results presented in report No. 600408-01 of: 06.03.2006

in accordance wîth § 17 of Council Directive 93/42/EEC, inci. amendments the above specified medical device must be

labelledCE1014.

The certifıed

manufacturer is subject to a surveillance audit by the noti f ied body in accordance with section 4 of Annex

inci. amendments, Cerîificate

manufacturer must inform the noti f ied body abo ut any intention resulting in signİficant modification of qualiry system

ör scope of included medical products. in the event that the conditions under which the Certi f icate has been issued are

violated,

the

notified body

may

suspend

the Certi f icate 's validity

ör

cancel

the

Certificate.

The validity of Certificate is limited to: 31.3.2011

Prague

Paveİ Kudraa

Certification and inspection Manager

Stamp

600408-01

 

E L E K T R O T E C H N I C K Y

Z K U S E B N İ

Ü S T A V

S

3 0 0 4

ELECTROTECHNİCAL

TESTING INSTİTUTE - CZECH REPUBLIC

ELEKTROTECHNISCHE F R Ü F A N S T A L T - TSCHECHISCHE

EEPUBLIK

INSTİTUT

ELECTROTECHNIQUE D'ESSAIS -

REPUBLIQUE TCHEOUE

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HHCTHTYT

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PECnVEJIHKA

Pod lisem 129, 171 02 Praha 8 - Troja

T he Electrotechnical Tesî ing Institute, the Certification Bod y N o 3004, accredited by the Czech Institute fo r Accreditation, o.p.s.

in accordance with ĞSN EN 45012, grants th e

CERTIFICATE

No.: 8060038

fo r

th e Qual ity System in accordance with ^_

EN ISO 13485:2003

to th e

Firm

HİJYEN GIDA KİM YA İLAÇ SAN AYİ

V E TİCARET LTD. ŞTİ .

Cumhuriyet Mah. Atatürk Bulvarı

Kalite Konut Apt. N o:

19

D :6

B.Çekmece, İSTANBUL,

Turkey

b e c a u s e

it

ascertained that

th e

Q u a l i t y System of the

Firm

in the

f ıe l d :

complies

with

requirements of the mentioned Standard docurnented by the Report No.; 600408-01 of : 06.03.2006

Th e val id i ty of the

Certificate

is limited till: 31.3.2009

T he Certified

Organization

İs subject to annual check-ups carried out by the Certification B o d y . A n y change within the

organization

conceming th e Certification shall be fo l lowed up and approved by the Electrotechnical Testing Institute. The val idity of this Certificate

may be suspended ör cancelled in the

event

of non-compliance with th e Standard on the

basis

of which the Certificate w as issued.

Prague

Pavel Kudrna

Certification

and Inspection Manager

600408-01