Fully Automated Nucleic Acid Extractor
by Yantai Addcare Bio-Tech Co., Ltd. China EUDAMED
Ref （01）6973609150565（11）210103（21）5562021001Model NA4424 EMDN W02050199
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697360915056KZ | Date27 Dec 2021 | StatusWithdrawn |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Withdrawn
Specification
- Device Name
- Fully Automated Nucleic Acid Extractor
- Model / Reference
- NA4424, （01）6973609150565（11）210103（21）5562021001
- Primary DI / UDI-DI
- 06973609150565
- Basic UDI-DI
- 697360915056KZ
- Direct Marketing DI
- 06973609150565
- EMDN Code
- W02050199 Nucleic acid testing instruments except micro-arrays - other
- 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 103a54f7-44d1-488f-8d40-a487096db8cd