3.3 BIOFIBRE® AND IMPLANT INSTRUMENTS QUALITY CERTIFICATES
Certifications of Medicap Ltd.
The Italian Istituto Superiore di Sanità - Notified Body CE 0373 - released the following certificates to Medicap Ltd. :
CE CERTIFICATE
according to Annex III of Directive 93/42/EEC
enforced by Law Decree no. 46 issued on 24.02.1997
Certificate no. 059 CTP 260 addendum /// released on 01.12.2006
APPROVAL OF QUALITY ASSURANCE SYSTEM
FOR PRODUCTION AND/OR STERILIZATION
according to Annex V of Directive 93/42/EEC
enforced by Law Decree no.46 issued on 24.02.1997
Certificate n° 059 QPZ 626 addendum /// released on 01.12.2006
TGA (Therapeutic Goods Administration, Commonwealth Department of
Health and Family Services),
on 28.05.2007, with certificate no. 139377, renewed the
inclusion of BIOFIBRE® CE 0373/TGA, manufactured by Medicap Ltd.,
in the Australian Register of Therapeutic Goods.
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