Labtub
by Lingen Precision Medical Products (Shanghai) Co., Ltd. China EUDAMED
Ref 032302110101Model K2EDTA
EMDN W050101010201
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number69736472901K2E016S | Date25 Nov 2021 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Blood Collection Tubes
- Model / Reference
- K2EDTA, 032302110101
- Primary DI / UDI-DI
- 06973647290117
- Basic UDI-DI
- 69736472901K2E016S
- EMDN Code
- W050101010201 Blood collection, tubes with additives or serum separator
- Device Class
- Class A
- Market of Registration
- France
Manufacturer details
- EUDAMED SRN
- CN-MF-000014163
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
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Properties & raw data
Show properties, registry sources and raw records
Other properties (11)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED 71107f6d-5ead-4968-98c4-1112f4abcc75