Lioncare
by Hubei Lioncare Protective Products Co., Ltd 3 variants
Ref S101E, LCS601, S109, C700BT, H103, LCF201, LCS601-L3, C500Model LCS604K,LCS601,LCS601-L3 LCS609K,LCS601RF, S101E,S101K,S107E, S106,S107K,S109, S403, S503,P103,S103, O301,O301AS,O308,O309,O406,O407AS, O601,C500BT,C500BTAS,C700BT,C700BTAS,C900BCAS, H101,H103,H201S,H201D,H301,H303,H401, H411,H501,H511,H601,H701,H711,H806, R720,R820V,R830V, R930,R930V,F214, LCF201,F202,F204, F205,F211,F212,LCF201K, C500, C700, C900, C500-BT, C700-BT, C900-BT ,C900-SP
Active
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 | Number697426174ISOLATIONGOWNE9 | Date13 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- Withdrawn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
- Disposable Medical GownDisposablemedicalshoe/BootcoversDisposable Medical CapDisposable Surgical Face MaskDisposable Medical Coverall
- Model / Reference
- LCS604K, LCS601, LCS601-L3 LCS609K, LCS601RF, S101E, S101K, S107E, S106, S107K, S109, S403, S503, P103, S103, O301, O301AS, O308, O309, O406, O407AS, O601, C500BT, C500BTAS, C700BT, C700BTAS, C900BCAS, H101, H103, H201S, H201D, H301, H303, H401, H411, H501, H511, H601, H701, H711, H806, R720, R820V, R830V, R930, R930V, F214, LCF201, F202, F204, F205, F211, F212, LCF201K, LCS601-L3, C500, C700, C900, C500-BT, C700-BT, C900-BT, C900-SP
- Primary DI / UDI-DI
- 16974261749156, 06974261740828, 06974261740903, 06974261740644, 06974261740873, 06974261740811, 06974261740385, 16974261749194, 06974261740835, 16974261749316, 16974261749163, 06974261740804, 06974261740200, 06974261740781, 16974261749170, 06974261740842, 16974261749187, 06974261740453, 16974261749200
- Basic UDI-DI
- 697426174ISOLATIONGOWNE9, 697426174SHOEBTCOVERTT, 697426174CAPRJ, 697426174MASKNS, 697426174COVERALLHE
- EMDN Code
- T0299, T0208, T0207, T020604
- Device Class
- Class I
- EU market of registration
- CyprusAustriaSloveniaPolandSpainLithuania
Manufacturer details
- EUDAMED SRN
- CN-MF-000020615
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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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