Identity
- Device Name
- Shoe Covers EUDAMED
- Model / Reference
- S, M, L, XL,2XL,3XL EUDAMEDS EUDAMEDL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975063460600 EUDAMED16975063460621 EUDAMED
- Basic UDI-DI
- 697506346shoesGY EUDAMED
- EMDN Code
- T0208 SHOE COVERS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMEDAustria 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 Covers by Xiantao Fushi 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 | 697506346shoesGY | Class I | Active |
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Manufacturer
- Manufacturer
- Xiantao Fushi Protective Products Co., Ltd
- EUDAMED SRN
- CN-MF-000017275
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED ba07a134-c997-4f4a-bea5-b04aaa5324fd 61 fields · synced Jun 20, 2026
- EUDAMED 8451ece5-4284-410d-870e-5eb39385f832 61 fields · synced Jun 20, 2026