YJSeq 300 Dx Sequencing System
by Shanghai YJMED BioTechnology Co., Ltd. China EUDAMED
Ref FCH-D SE075-DModel YJSeq 300 Dx Kit EMDN W02050185
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697733421RB01KG | Date10 Jun 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- YJSeq 300 Dx Sequencing Kit
- Model / Reference
- YJSeq 300 Dx Kit, FCH-D SE075-D
- Primary DI / UDI-DI
- 06977334213052
- Basic UDI-DI
- 697733421RB01KG
- EMDN Code
- W02050185 Nucleic acid testing instruments except micro-arrays - consumables
- Device Class
- Class A
- Market of Registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000055692
- Authorised representative
- Medunion S.L. ES-AR-000019366
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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 500b41bb-5910-4161-b18c-4520a1f60e67