Allplex™ Entero-DR Assay
by Seegene, Inc. United States EUDAMED
Ref CR10384Z EMDN W0104080607
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-08809240103845 | Date15 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD Expiring
Specification
- Model / Reference
- CR10384Z
- Primary DI / UDI-DI
- 08809240103845
- Basic UDI-DI
- B-08809240103845
- EMDN Code
- W0104080607 Nucleic acid identification - manual / automated other resistance markers
- Device Class
- Class IVD General
- 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 (6)
- Sterile: No
- Human Tissues: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (1)
- EUDAMED f7002150-8e35-4e19-9fb5-135b271c284f