Identity
- Trade Name
- Cerdak Digitip EUDAMEDCerdak Ceramic Wound Dressing EUDAMED
- Device Name
- Cerdak Digitip EUDAMED
- Model / Reference
- Aerocloth EUDAMEDS02055080 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06009668350315 EUDAMED
- Basic UDI-DI
- B-06009668350315 EUDAMED
- EMDN Code
- M04010101 NON-WOVEN 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 Digitip 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-06009668350315 | 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 59eda2ca-04a0-4b92-a662-ea06fca033a0 61 fields · synced Jun 19, 2026
- EUDAMED 9403fc60-c7b2-4ef2-af05-13f0b5024513 61 fields · synced Jun 19, 2026