MicroScan Neg MIC Panel Type 63
by Beckman Coulter Inc. United States EUDAMED
Ref C80300
EMDN W0203010185
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-C80300V8 | Date17 Jun 2022 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/IVDD Expiring (legacy directive)
Specification
- Device Name
- MicroScan Neg MIC/Combo Panel Family
- Model / Reference
- C80300
- Primary DI / UDI-DI
- D-C80300V8, 15099590749866
- Basic UDI-DI
- B-C80300V8, 15099501MCOVNEGQN
- Unit of Use DI
- 05099590749678
- EMDN Code
- W0203010185 Antibiotic susceptibility analysers - consumables
- Device Class
- Class IVD GeneralClass B
- Market of Registration
- Ireland
Manufacturer details
- EUDAMED SRN
- US-MF-000010288
- Authorised representative
- Beckman Coulter Ireland Inc. IE-AR-000000886
Other devices from Beckman Coulter, 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 2a581151-8049-46c2-be36-3657e41ce486
- EUDAMED 15099590749866|15099501MCOVNEGQN