Genetic Sequencer G100-E
by BGI Hangzhou CycloneSEQ Technology Co., Ltd. China EUDAMED
Ref H900-000022Model G100-E EMDN W02050108
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697928045SEQXW | Date5 Jun 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Genetic Sequencer
- Model / Reference
- G100-E, H900-000022
- Primary DI / UDI-DI
- 06979280450000
- Basic UDI-DI
- 697928045SEQXW
- Direct Marketing DI
- 06979280450000
- EMDN Code
- W02050108 Genetic system readers
- Device Class
- Class A
- Market of Registration
- Latvia
Manufacturer details
- EUDAMED SRN
- CN-MF-000051828
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from BGI Hangzhou CycloneSEQ Technology 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
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- New Device: No
Sources (1)
- EUDAMED 7989adc3-63c0-4f9b-b962-1f8a8c9af7ec