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Certificate Number: CE 00493
Scope: The manufacture of sterile transparent wound dressings with and without pads, electronic stethoscopes and associated software, sterile skin staplers and sterile drapes (wound protector, isolation bag), barrier film dressings, and sterile disinfecting port protector devices.
Those aspects of Annex V relating to securing and maintaining sterility in the manufacture of wound closures, wound dressings, drapes, barrier film wraps, staple removers, patient warming blankets and securement devices.
Those aspects of manufacturing relating to obtaining sterility in the assembly of procedure packs in accordance with Article 12 of the Medical Device Directive.
Original Registration Date | Effective Date | Last Revision Date | Expiry Date |
---|---|---|---|
1995-02-01 | 2020-07-10 | 2024-05-26 |