eazyplex® Pneumocystis jirovecii
by AmplexDiagnostics GmbH Germany EUDAMED
Ref 7626 EMDN W0105060405
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number425059237626A3 | Date3 Sep 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- eazyplex® Pneumocystis jirovecii
- Model / Reference
- 7626
- Primary DI / UDI-DI
- 04250592376267
- Basic UDI-DI
- 425059237626A3
- EMDN Code
- W0105060405 Pneumocystis - na reagents
- Device Class
- Class C
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000014117
Other devices from AmplexDiagnostics GmbH
Properties & raw data
Show properties, registry sources and raw records
Other properties (10)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED 00fd8ec9-07bf-48dc-9ed9-1e2481a3c7b2