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Cerdak Aerocloth 10x26 cm
EUDAMEDClass IIb (EU MDR)
Ref C06045200Model Aerocloth
Identity
- Trade Name
- Cerdak Aerocloth 10x26 cm EUDAMEDCerdak Ceramic Wound Dressing EUDAMED
- Device Name
- Cerdak Aerocloth 10x26 cm EUDAMED
- Model / Reference
- Aerocloth EUDAMEDC06045200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06009668350162 EUDAMED
- Basic UDI-DI
- B-06009668350162 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 Aerocloth 10x26 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-06009668350162 | 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 3c9e5e84-1984-4308-8dfb-ba29e18edf67 61 fields · synced Jun 19, 2026
- EUDAMED d320c8a9-9654-47ad-b434-4743aefe4093 61 fields · synced Jun 19, 2026