Identity
- Trade Name
- Shoe Cover EUDAMED
- Device Name
- Shoe Cover EUDAMED
- Model / Reference
- MD1101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975549101102 EUDAMED
- Basic UDI-DI
- 697554910110MA EUDAMED
- EMDN Code
- T0208 SHOE COVERS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Greece 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 Medex International 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 | 697554910110MA | Class I | Active |
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Manufacturer
- Manufacturer
- Medex International Ltd
- EUDAMED SRN
- CN-MF-000034328
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED a525115b-792b-4bee-aa75-b89dda9b1872 61 fields · synced Jun 20, 2026