MicroScan MSF FAST MIC Panel Type 2
by Beckman Coulter Inc. United States EUDAMED
Ref C32700
EMDN W0203010185
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | NumberB-C32700UK | Date9 Jun 2022 | StatusActive |
| European Union | CE/IVDD | NumberB-C32700UK | Date9 Jun 2022 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR, CE/IVDD Active
Specification
- Device Name
- MicroScan MICroSTREP plus Panel Family
- Model / Reference
- C32700
- Primary DI / UDI-DI
- D-C32700UK, 15099590722272
- Basic UDI-DI
- B-C32700UK, 15099501MCSTREPSS
- Unit of Use DI
- 05099590722275
- 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 4ce79b3a-91c8-4e5e-8b9f-c37d9668776e
- EUDAMED 15099590722272|15099501MCSTREPSS