Identity
- Trade Name
- Cerdak Aerofilm 10x21 cm EUDAMEDCerdak Ceramic Wound Dressing EUDAMED
- Device Name
- Cerdak Aerofilm 10x21 cm EUDAMED
- Model / Reference
- Aerofilm EUDAMEDF05045150 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06009668350223 EUDAMED
- Basic UDI-DI
- B-06009668350223 EUDAMED
- EMDN Code
- M04010102 POLYURETHANE (OR OTHER MATERIAL) ADHESIVE DRESSINGS, WITH ABSORBENT PAD EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Slovakia EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Cerdak Aerofilm 10x21 cm by Cerdak (Pty) Ltd — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06009668350223 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Cerdak (Pty) Ltd
- EUDAMED SRN
- ZA-MF-000010888
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 07973ac8-1ed6-4d47-9bbd-a811e7ce11bc 61 fields · synced Jun 19, 2026
- EUDAMED 2d3fd861-042f-420d-a4ff-8c67984364dd 61 fields · synced Jun 19, 2026