Universal Sequencing Reaction Kit T1+ FCL SE50
by Shenzhen MGI Biological Electronic Technology Co., Ltd. China EUDAMED
Ref 940-002752-00 EMDN W010699
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697599627S-Kit35 | Date1 Jun 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Universal Sequencing Reaction Kit
- Model / Reference
- 940-002752-00
- Primary DI / UDI-DI
- 06975996270321
- Basic UDI-DI
- 697599627S-Kit35
- EMDN Code
- W010699 Genetic tests - other
- Device Class
- Class A
- Market of Registration
- Latvia
Manufacturer details
- EUDAMED SRN
- CN-MF-000044825
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
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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
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED 9a967b26-5bb2-42cf-a69a-b341e2ce8b4f