Identity
- Trade Name
- Shoe Cover EUDAMED
- Device Name
- Shoe Cover EUDAMED
- Model / Reference
- 4852 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 74895237103106 EUDAMED
- Basic UDI-DI
- 48952371510VK EUDAMED
- EMDN Code
- T0208 SHOE COVERS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Shoe Cover by Kenpax International Limited — 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 | 48952371510VK | Class I | Active |
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Manufacturer
- Manufacturer
- Kenpax International Limited
- EUDAMED SRN
- HK-MF-000021152
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 8c348ba0-bfcd-4106-a6a9-a8692bc301cb 61 fields · synced Jun 18, 2026