Identity
- Device Name
- Shoe cover EUDAMED
- Model / Reference
- 15x40cm, 16x42cm or customized EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974169915014 EUDAMED
- Basic UDI-DI
- 697416991ShoecoverEX EUDAMED
- EMDN Code
- T0208 SHOE COVERS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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 Xiantao Xinri 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 | 697416991ShoecoverEX | Class I | Active |
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Manufacturer
- Manufacturer
- Xiantao Xinri Protective Products Co., Ltd
- EUDAMED SRN
- CN-MF-000009835
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED a444a338-bdc2-435d-999d-8384f1707456 61 fields · synced Jul 20, 2026
- EUDAMED a444a338-bdc2-435d-999d-8384f1707456-1 61 fields · synced Jun 9, 2026