Disposable shoe cover
by Hubei Yazhi Hygiene Products Co., Ltd 3 variants
Ref Standard
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697480528ShoeCover2B | Date30 May 2023 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Disposable shoe cover
- Model / Reference
- Standard
- Primary DI / UDI-DI
- 08435454004212, 08435454004250, 08435454004939, 08435454004885, 08435454004229, 08435454004861, 08435454004243, 08435454004380
- 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
Other devices from Hubei Yazhi Hygiene Products Co., Ltd
See all devices from Hubei Yazhi Hygiene Products Co., Ltd →
Properties
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