Shoe Cover
by Hubei V-Medical Products Co., Ltd.
Ref 105.2, 090205Model 41x15cm 39x15cm 40x16cm 40x17cm 41x17cm 41x18cm 42x17cm 42x18cm 43x17cm 48x17cm
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 | Number697023378NWShoeCoversKP | Date8 Aug 2022 | 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- Withdrawn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 Covers 鞋套
- Model / Reference
- 41x15cm 39x15cm 40x16cm 40x17cm 41x17cm 41x18cm 42x17cm 42x18cm 43x17cm 48x17cm, 105.2, 090205
- Primary DI / UDI-DI
- 06970233788409, 06970233786276
- Basic UDI-DI
- 697023378NWShoeCoversKP
- Secondary DI
- 16970233788406
- Unit of Use DI
- 16970233786273
- EMDN Code
- T0208 Shoe covers (excluding personal protective equipment - PPE)
- Device Class
- Class I
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- CN-MF-000011268
- Authorised representative
- RAFFIN MEDICAL FR-AR-000004632
Other devices from Hubei V-Medical 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