Automatic Nucleic Acid Workstation
by Xi'an Tianlong Science and Technology Co., Ltd. EUDAMED
Active
Ref Y964HModel PANA 9600S, PANA 9600X, PANA 3200S, PANA 3200S+
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697488477TLH004YV | Date10 Jul 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Automatic Nucleic Acid Workstation
- Model / Reference
- PANA 9600S, PANA 9600X, PANA 3200S, PANA 3200S+, Y964H
- Primary DI / UDI-DI
- 06974884777645
- Basic UDI-DI
- 697488477TLH004YV
- EMDN Code
- W02050106 DNA genomic preparation devices
- Device Class
- Class A
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000001079
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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Properties
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