ELEKTROTECHNICKY ZKUSEBNI USTAV

ELECTROTECHNICAL TESTING INSTİTUTE - CZECH REPUBLIC

ELEKTROTECHN1SCHE PRÜFANSTALT - TSCHECfflSCHE REPUBLIK
MSTITUT ELECTRÛTECHNIQUE D'ESSAIS - REPUBLIQUE TCHEQUE
3JffiKTPOTEXHHHECKHH HCntrTATEJItHBIÎİ HHCTmVT - HElHCKAfl PECnVBJlHKA

Pod lisem 129,171 02 Praha 8 - Troja

CE - CERTIFICATE
of production quality assurance

No.: MED 060019

The Electrotechnical Testing Institute, Notifıed 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

for manufacture and final inspection of medical devices

Manufacturing and sales of medical disinfectants

complies with provisions of Annex V section 3 of the 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 notified body in accordance with section 4 of Annex
V of Council Directive 93/42/EEC inci. amendments, and validity of the Cerîificate is subject to regular supervision. The
manufacturer must inform the notified body about any intention resulting in signİficant modification of qualiry system
ör scope of included medical products. in the event that the conditions under which the Certificate has been issued are
violated, the notified body may suspend the Certificate'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
ELEKTROTECHNICKY ZKUSEBNİ ÜSTAV

ELECTROTECHNİCAL TESTING INSTİTUTE - CZECH REPUBLIC

ELEKTROTECHNISCHE FRÜFANSTALT - TSCHECHISCHE EEPUBLIK
INSTİTUT ELECTROTECHNIQUE D'ESSAIS - REPUBLIQUE TCHEOUE
!UIEKTPOTEXHMHECKHÎÎ HCITBn'ATEntHLlS HHCTHTYT - HEIUCKA3 PECnVEJIHKA

S 3004 Pod lisem 129, 171 02 Praha 8 - Troja

The Electrotechnical Tesîing Institute, the Certification Body No 3004, accredited by the Czech Institute for Accreditation, o.p.s.
in accordance with ĞSN EN 45012, grants the

CERTIFICATE
No.: 8060038

for the Quality System in accordance with ^_

EN ISO 13485:2003
to the Firm

HİJYEN GIDA KİMYA İLAÇ SANAYİ

VE TİCARET LTD. ŞTİ.
Cumhuriyet Mah. Atatürk Bulvarı Kalite Konut Apt. No: 19 D:6
B.Çekmece, İSTANBUL, Turkey

because it ascertained that the Quality System of the Firm in the fıeld:

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

The validity of the Certificate is limited till: 31.3.2009

The Certified Organization İs subject to annual check-ups carried out by the Certification Body. Any change within the organization
conceming the Certification shall be followed up and approved by the Electrotechnical Testing Institute. The validity of this Certificate
may be suspended ör cancelled in the event of non-compliance with the Standard on the basis of which the Certificate was issued.

Prague Pavel Kudrna

Certification and Inspection Manager

600408-01