Disposable Shoe Cover
by Xiantao City Songqing Plastic Products Co., Ltd 3 variants
Ref 17x40cm, customize, 16x41cm, 15x39cmModel 15x39cm, 15x40cm, 16x41cm, 17x40cm, 17x42cmor customize
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 | Number697708242ShoeCoverX6 | Date27 May 2025 | 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- Withdrawn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
- 15x39cm, 15x40cm, 16x41cm, 17x40cm, 17x42cmor customize, customize
- Primary DI / UDI-DI
- 06977082420238, 06977082420252, 06977082420221, 06977082420207
- Basic UDI-DI
- 697708242ShoeCoverX6
- EMDN Code
- T0208 Shoe covers (excluding personal protective equipment - PPE)
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000003396
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Xiantao City Songqing Plastic Products Co., Ltd
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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