Identity
- Trade Name
- Disposable Shoe Cover EUDAMED
- Device Name
- Disposable Shoe Cover EUDAMED
- Model / Reference
- SC1035-UN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710415369079 EUDAMED
- Basic UDI-DI
- 5745001204SC1035UNVG EUDAMED
- EMDN Code
- T0208 SHOE COVERS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark 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
Disposable Shoe Cover by Medtecs (Cambodia) Corp, 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 | 5745001204SC1035UNVG | Class I | Active |
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Manufacturer
- Manufacturer
- Medtecs (Cambodia) Corp, Ltd.
- EUDAMED SRN
- KH-MF-000029845
- Authorised Representative
- Luana Med. B.V. NL-AR-000002750
Sources (1)
- EUDAMED eac063ec-95b5-4088-a354-7059339d669d 61 fields · synced Jun 20, 2026