Disposable shoe cover
by Hubei Yazhi Hygiene Products Co., Ltd China EUDAMED
Ref Standard
EMDN T0208
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697480528ShoeCover2B | Date30 May 2023 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Disposable shoe cover
- Model / Reference
- Standard
- Primary DI / UDI-DI
- 08435454004366, 08435454004236, 08435454004946
- Basic UDI-DI
- 697480528ShoeCover2B
- EMDN Code
- T0208 Shoe covers (excluding personal protective equipment - PPE)
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000010782
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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See all devices from Hubei Yazhi Hygiene Products Co., Ltd →
Properties & raw data
Show properties, registry sources and raw records
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (3)
- EUDAMED ce69cdaf-e921-475d-bd65-756006c9e3d8
- EUDAMED 08435454004236|697480528SHOECOVER2B
- EUDAMED 08435454004946|697480528SHOECOVER2B