Real-time PCR System
by Xi'an Tianlong Science and Technology Co., Ltd. China EUDAMED
Ref Y959HModel Gentier Sp96E, Gentier Sp96R, Gentier Sp96X, Gentier Sp96V, Gentier Sp384E, Gentier Sp384R
EMDN W02050106
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697488477TLH015Z2 | Date4 Aug 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Real-time PCR System
- Model / Reference
- Gentier Sp96E, Gentier Sp96R, Gentier Sp96X, Gentier Sp96V, Gentier Sp384E, Gentier Sp384R, Y959H
- Primary DI / UDI-DI
- 06974884777614
- Basic UDI-DI
- 697488477TLH015Z2
- 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
Other devices from Xi'an Tianlong Science and Technology Co., Ltd.
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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 42658767-a886-4119-9c14-7d81673e48c6