Real-time PCR System
by Xi'an Tianlong Science and Technology Co., Ltd. 19 variants
Ref TL59BRHModel Gentier Sp96E, Gentier Sp96R, Gentier Sp96X, Gentier Sp96V, Gentier Sp384E, Gentier Sp384R
Active
CE IVDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697488477TLH015Z2 06974884776334 | Date4 Aug 2025 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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, TL59BRH
- Primary DI / UDI-DI
- 06974884776334
- Basic UDI-DI
- 697488477TLH015Z2
- EMDN Code
- W02050106 DNA genomic preparation devices
- Device Class
- Class A
- EU market of registration
- Netherlands
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
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