Cuvettes
by Shanghai Sun Biotech Co., Ltd. China EUDAMED
Ref B018E, B012E, B026E, B025E, B016E, B010E EMDN W0202020185
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69382472Cuvettes-20S6 | Date28 Oct 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Cuvettes
- Model / Reference
- B018E, B012E, B026E, B025E, B016E, B010E
- Primary DI / UDI-DI
- 06938247222302, 06938247211306, 06938247231212, 06938247231205, 06938247222296, 06938247211290
- Basic UDI-DI
- 69382472Cuvettes-20S6
- EMDN Code
- W0202020185 Coagulometers - consumables
- Device Class
- Class A
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000027682
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
Other devices from Shanghai Sun Biotech Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (10)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (6)
- EUDAMED 055c6c1e-722c-4047-8afb-24ed92c726e1
- EUDAMED 06938247211306|69382472CUVETTES-20S6
- EUDAMED 06938247231212|69382472CUVETTES-20S6
- EUDAMED 06938247231205|69382472CUVETTES-20S6
- EUDAMED 06938247222296|69382472CUVETTES-20S6
- EUDAMED 06938247211290|69382472CUVETTES-20S6