Identity
- Trade Name
- Shoe Cover EUDAMED
- Device Name
- Shoe Cover EUDAMED
- Model / Reference
- 4850 EUDAMED2854 EUDAMED4854 EUDAMED2852 EUDAMED4872A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 74895237103090 EUDAMED74895237103083 EUDAMED74895237103113 EUDAMED74895237103076 EUDAMED74895237103120 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 (5)
- EUDAMED 45d01f1a-4383-4ff9-ab43-fc1d9a09e882 61 fields · synced Aug 1, 2026
- EUDAMED f22c5d04-b360-4e04-8aa6-92cab0988de7 61 fields · synced May 18, 2026
- EUDAMED daf10f81-60b5-4ec3-9fcd-c9eca08a42e4 61 fields · synced May 18, 2026
- EUDAMED c8f3fd48-7b1c-4450-a2c6-675646925e6c 61 fields · synced May 18, 2026
- EUDAMED 19e8ffd9-9a4a-4771-886b-a4e6ba067c8c 61 fields · synced May 19, 2026