Fully Automated CLIA Workstation
by Yantai Addcare Bio-Tech Co., Ltd. China EUDAMED
Ref （01）6973609150800（11）210110（21）5802021001Model iTube 3000 EMDN W0201020103
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697360915080KW | Date27 Dec 2021 | StatusWithdrawn |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Withdrawn
Specification
- Device Name
- Fully Automated CLIA Workstation
- Model / Reference
- iTube 3000, （01）6973609150800（11）210110（21）5802021001
- Primary DI / UDI-DI
- 06973609150800
- Basic UDI-DI
- 697360915080KW
- Direct Marketing DI
- 06973609150800
- EMDN Code
- W0201020103 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 test/h)
- Device Class
- Class A
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000018409
- Authorised representative
- Lepu Medical (Europe) Cooperatief U.A. NL-AR-000000551
Other devices from Yantai Addcare Bio-Tech Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- New Device: No
Sources (1)
- EUDAMED a5750e8d-7cef-4dcb-b233-a0195c2da95a