All-in-one Molecular Diagnosis System
by Xi'an Tianlong Science and Technology Co., Ltd. China EUDAMED
Ref Y935HModel Panall X1600 EMDN W02050116
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697488477TLH022YX | Date12 Oct 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- All-in-one Molecular Diagnosis System
- Model / Reference
- Panall X1600, Y935H
- Primary DI / UDI-DI
- 06974884774118
- Basic UDI-DI
- 697488477TLH022YX
- EMDN Code
- W02050116 Nucleic acid testing integrated extraction /amplification /detection systems
- 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 06974884774118|697488477TLH022YX