Calibrator-Set: (DBS Calibrator-Set – Level 0-6 for Lyso Triplex)
by ARCHImedline GmbH Austria EUDAMED
Ref A290-011 EMDN W0101050301
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number1912013223A290-011VP | Date10 Jun 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Calibrator-Set: (DBS Calibrator-Set – Level 0-6 for Lyso Triplex)
- Model / Reference
- A290-011
- Primary DI / UDI-DI
- 09120132230029
- Basic UDI-DI
- 1912013223A290-011VP
- Direct Marketing DI
- 09120132230029
- EMDN Code
- W0101050301 Calibrators multicomponent (cc)
- Device Class
- Class B
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- AT-MF-000037501
Other devices from ARCHImedline GmbH
Properties & raw data
Show properties, registry sources and raw records
Other properties (8)
- Sterile: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (1)
- EUDAMED 07a010a2-eab2-413e-9da7-e9707b730eea