FagoFlowEx Kit
by EXBIO Praha, a.s. EUDAMED
Active
Ref ED7042
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-08594208060123 | Date24 Jun 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD Expiring
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- FagoFlowEx Kit
- Model / Reference
- ED7042
- Primary DI / UDI-DI
- 08594208060123
- Basic UDI-DI
- B-08594208060123
- EMDN Code
- W010399 Haematology / haemostasis / immunohaematology / histology / cytology reagents - other
- Device Class
- Class IVD General
- Market of Registration
- Czechia
Manufacturer details
- EUDAMED SRN
- CZ-MF-000033468
Other devices from EXBIO Praha, a.s.
Properties
Other properties (6)
- Sterile: No
- Human Tissues: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No