Bd Facsdiva
by Becton, Dickinson and Company, BD Biosciences
Ref 656046
Active
CE IVDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number038290CBFJJSUFY6 00382906560469 | Date11 Sep 2026 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- BD FACSDiva CS&T IVD Beads (50 tests)
- Model / Reference
- 656046
- Primary DI / UDI-DI
- 00382906560469
- Basic UDI-DI
- 038290CBFJJSUFY6
- EMDN Code
- W0103080401 Setup beads
- Device Class
- Class A
- EU market of registration
- Belgium
Manufacturer details
- EUDAMED SRN
- US-MF-000017797
- Authorised representative
- Becton Dickinson Ireland Limited IE-AR-000007610
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Properties
Other properties (7)
- Sterile: No
- Human Tissues: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No