Identity
- Trade Name
- Cerdak Ceramic Wound Dressing EUDAMED
- Device Name
- Cerdak Basic 21x30 cm EUDAMED
- Model / Reference
- Basic EUDAMEDS11210295 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06009668350100 EUDAMED
- Basic UDI-DI
- B-06009668350100 EUDAMED
- EMDN Code
- M04010101 NON-WOVEN ADHESIVE DRESSINGS, WITH ABSORBENT PAD EUDAMEDM040299 NON-ADHESIVE ABSORBENT DRESSINGS - OTHER 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 Basic 21x30 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-06009668350100 | 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 c9c44ae5-c60a-4c80-b2b8-7e8724153b9e 61 fields · synced Jun 18, 2026
- EUDAMED 816e9868-39ef-4662-bb95-9bdbbbfbd6e7 61 fields · synced Jun 18, 2026