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Cerdak Aerofilm 12.5x12.5 cm
EUDAMEDClass IIb (EU MDR)
Ref F09125125Model Aerofilm
Identity
- Trade Name
- Cerdak Aerofilm 12.5x12.5 cm EUDAMEDCerdak Ceramic Wound Dressing EUDAMED
- Device Name
- Cerdak Aerofilm 12.5x12.5 cm EUDAMED
- Model / Reference
- Aerofilm EUDAMEDF09125125 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06009668350414 EUDAMED
- Basic UDI-DI
- B-06009668350414 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 12.5x12.5 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-06009668350414 | 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 edae29f0-fb25-4833-aaf2-fe69704f9b31 61 fields · synced Jun 19, 2026
- EUDAMED b0d4bac6-c110-4495-aa83-97c082d6fa27 61 fields · synced Jun 19, 2026