Universal Sequencing Reaction Kit (Package II) E25 SM App-C FCL SE100
by Qingdao MGI Tech Co., Ltd. China EUDAMED
Ref 940-000616-00
EMDN W010699
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697485688S-KitZV | Date3 Jun 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Universal Sequencing Reaction Kit
- Model / Reference
- 940-000616-00
- Primary DI / UDI-DI
- 06974856880335
- Basic UDI-DI
- 697485688S-KitZV
- Direct Marketing DI
- 06974856880335
- EMDN Code
- W010699 Genetic tests - other
- Device Class
- Class A
- Market of Registration
- Latvia
Manufacturer details
- EUDAMED SRN
- CN-MF-000022546
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Qingdao MGI Tech Co., Ltd.
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 a3a7428d-5e55-46f6-babf-35d37aafeb57