Identity
- Trade Name
- Oakmed EUDAMED
- Device Name
- Oakmed Stoma Care and Wound Care products EUDAMED
- Model / Reference
- SCA45-4115KVBK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060577756545 EUDAMED
- Basic UDI-DI
- 506057775StomaCareR5 EUDAMED
- EMDN Code
- A1001010202,A1001020202,A1001030202 EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Oakmed by Oakmed Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 506057775StomaCareR5 | Class I | Active |
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Manufacturer
- Manufacturer
- Oakmed Ltd
- EUDAMED SRN
- UK-MF-000051482
- Authorised Representative
- Specculo Limited MT-AR-000034988
Sources (1)
- EUDAMED 359d018c-b3bf-44dd-a661-969f17b849a1 61 fields · synced Jun 17, 2026