SeekOne™ Digital Droplet System
by Beijing SeekGene BioSciences Co., Ltd China EUDAMED
Ref M001A EMDN W02029099
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697624137014KA | Date7 Jul 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- M001A
- Primary DI / UDI-DI
- 06976241370148
- Basic UDI-DI
- 697624137014KA
- Direct Marketing DI
- 06976241370148
- EMDN Code
- W02029099 Various hematology / histology / cytology instruments - other
- Device Class
- Class A
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000034144
- Authorised representative
- MedPath GmbH DE-AR-000000087
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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 2cea18d1-a51f-44d7-a64f-fa9919c8dbe0