Fully Automated CLIA Workstation
by Yantai Addcare Bio-Tech Co., Ltd. China EUDAMED
Ref （01）6973609150176（11）210112（21）5A92021001Model iTube 1000 EMDN W0201020101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697360915017KP | 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- Withdrawn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European Union — CE/IVDR Withdrawn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 1000, （01）6973609150176（11）210112（21）5A92021001
- Primary DI / UDI-DI
- 06973609150176
- Basic UDI-DI
- 697360915017KP
- Direct Marketing DI
- 06973609150176
- EMDN Code
- W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 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 2972d53c-faae-46fa-a7cc-4a1cfddbd4b9