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ENDOFOM PROTEZ SÜNGER SAN. VE TİC. LTD. ŞTİ. Sayim Çıkrıkçı Caddesi No.78 Kısıkköy İzmir, as Manu-

facturer with Responsibility Declares that all medical products of the below Mentioned product

groups bear The Ce mark and conform with the Basic requirements of the council directive

93/42/eec On Medical Products.

Product Groups

1) Lower and Upper extrimity Cosmetic prosthetic foam covers,

2) Lower and Upper extrimity prosthetic modular conventional Systems.

3) Lower and Upper extrimity orthotic devices includung hip, knee&ankle joints with side bars.

4) Lower and upper extrimity orthotic Device’s substitute parts and side products.

Risk Category: All products listed in annex A belong to risk category 1

Other Indications: The Quality management system of ENDOFOM PROTEZ SÜNGER SAN. VE TİC. LTD. ŞTİ.



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