Identity
- Trade Name
- Cerdak Ceramic Wound Dressing EUDAMED
- Device Name
- Cerdak Umbilicus 1.5 cm EUDAMED
- Model / Reference
- Basic EUDAMEDS06000015 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06009668350346 EUDAMED
- Basic UDI-DI
- B-06009668350346 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 Umbilicus 1.5 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-06009668350346 | 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 05b77282-9ad5-40ba-8742-5585894a2e3d 61 fields · synced Jun 18, 2026
- EUDAMED 1abcdf38-d084-4e74-a28f-faf7ed610edf 61 fields · synced Jun 18, 2026