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Non-woven Shoe Cover
EUDAMEDClass I (EU MDR)
Ref XSModel XS,S,M,L,XL,XXL,XXXL,XXXXL,or customized
Identity
- Device Name
- Non-woven Shoe Cover EUDAMED
- Model / Reference
- XS,S,M,L,XL,XXL,XXXL,XXXXL,or customized EUDAMEDXS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978335290608 EUDAMED
- Basic UDI-DI
- 697833529SHOECOVEREC 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
Non-woven Shoe Cover by Xiantao Zhengxin non woven 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 | 697833529SHOECOVEREC | Class I | Active |
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Manufacturer
- Manufacturer
- Xiantao Zhengxin non woven products Co., Ltd.
- EUDAMED SRN
- CN-MF-000048529
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 645875e8-6e43-4b28-9c72-dfed95e24ae6 61 fields · synced Oct 6, 2026