Fully Automated Molecular Testing System POCT
by Xi'an Tianlong Science and Technology Co., Ltd. China EUDAMED
Ref Y062HModel iGenebox 3A EMDN W02050301
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697488477TLH018Z8 | Date8 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Fully Automated Molecular Testing System POCT
- Model / Reference
- iGenebox 3A, Y062H
- Primary DI / UDI-DI
- 06974884776204
- Basic UDI-DI
- 697488477TLH018Z8
- EMDN Code
- W02050301 Nucleic acid testing apparatuses - rapid and point of care tests
- Device Class
- Class A
- Market of Registration
- Netherlands
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 06974884776204|697488477TLH018Z8