Identity
- Device Name
- Disposable Shoe Covers EUDAMED
- Model / Reference
- MDN1214 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975117813000 EUDAMED
- Basic UDI-DI
- 697511781XRSC0035A 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
Yes
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 Covers by Xiantao Xingrong Protective Products Co., 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 | 697511781XRSC0035A | Class I | Active |
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Manufacturer
- Manufacturer
- Xiantao Xingrong Protective Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000020687
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED a88f4938-8623-4a9b-8ac1-96bcb6aeec53 61 fields · synced Jun 18, 2026