Disposablemedicalshoe/Bootcovers
by Hubei Lioncare Protective Products Co., Ltd 2 variants
Ref O308Model O301,O301AS,O308,O309,O406,O407AS, O601,C500BT,C500BTAS,C700BT,C700BTAS,C900BCAS
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 | Number697426174SHOEBTCOVERTT | Date15 Jun 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- Withdrawn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
- Disposablemedicalshoe/Bootcovers
- Model / Reference
- O301, O301AS, O308, O309, O406, O407AS, O601, C500BT, C500BTAS, C700BT, C700BTAS, C900BCAS
- Primary DI / UDI-DI
- 06974261741931, 16974261747015
- Basic UDI-DI
- 697426174SHOEBTCOVERTT
- EMDN Code
- T0208 Shoe covers (excluding personal protective equipment - PPE)
- Device Class
- Class I
- EU market of registration
- Croatia
Manufacturer details
- EUDAMED SRN
- CN-MF-000020615
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
Other devices from Hubei Lioncare Protective Products Co., Ltd
See all devices from Hubei Lioncare Protective 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