PCR Thermal Cycler
by Xi'an Tianlong Science and Technology Co., Ltd. China EUDAMED
Ref Y007HModel Genesy
EMDN W02050106
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697488477TLH003YT | Date1 Aug 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- PCR Thermal Cycler
- Model / Reference
- Genesy, Y007H
- Primary DI / UDI-DI
- 06974884777904
- Basic UDI-DI
- 697488477TLH003YT
- 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 & 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 517f5ff9-5bfb-4a93-8c8a-b37fe231f300