Disposable Shoe Cover
by Operating Theatre Medical (Zhijiang) Co., Ltd 2 variants
Ref 343118Model Blue/green shoe cover for single use
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 | Number6976128076000BA 06976128076026 | Date19 Apr 2024 | 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- Withdrawn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
- Shoe cover for single use
- Model / Reference
- Blue/green shoe cover for single use, 343118
- Primary DI / UDI-DI
- 06976128076026
- Basic UDI-DI
- 6976128076000BA
- Unit of Use DI
- 16976128076023
- EMDN Code
- T0208 Shoe covers (excluding personal protective equipment - PPE)
- Device Class
- Class I
- Market of Registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000038254
- Authorised representative
- mono-uso nv BE-AR-000001322
Other devices from Operating Theatre Medical (Zhijiang) Co., Ltd
See all devices from Operating Theatre Medical (Zhijiang) 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