Identity
- Trade Name
- Cerdak Aerofilm 20x20 cm EUDAMEDCerdak Ceramic Wound Dressing EUDAMED
- Device Name
- Cerdak Aerofilm 20x20 cm EUDAMED
- Model / Reference
- Aerofilm EUDAMEDF08200200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06009668350377 EUDAMED
- Basic UDI-DI
- B-06009668350377 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 20x20 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-06009668350377 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cerdak (Pty) Ltd
- EUDAMED SRN
- ZA-MF-000010888
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 360e1c94-8dc5-4c9a-a30c-e4132ecd16ce 61 fields · synced Jun 17, 2026
- EUDAMED d4d079c7-75a3-4b1a-a04e-46fec071455c 61 fields · synced Jun 11, 2026