Allplex™ Meningitis-V1 Assay
by Seegene, Inc. United States EUDAMED
Ref MG10209Z EMDN W0105070505
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | NumberB-08809240102091 | Date13 May 2026 | StatusActive |
| European Union | CE/IVDD | NumberB-08809240102091 | Date13 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR, CE/IVDD Active
Specification
- Model / Reference
- MG10209Z
- Primary DI / UDI-DI
- 08809240102091
- Basic UDI-DI
- B-08809240102091, 924010MG97000HY
- EMDN Code
- W0105070505 Meningitis / encephalitis infections - multiplex na reagents
- Device Class
- Class IVD Annex II List BClass C
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- KR-MF-000022275
- Authorised representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Other devices from Seegene Inc.
Properties & raw data
Show properties, registry sources and raw records
Other properties (7)
- Sterile: No
- Human Tissues: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (2)
- EUDAMED 0e93c66a-213e-4099-8455-eaf68febe5d0
- EUDAMED 08809240102091|924010MG97000HY