Boost 4 IVD Centrifuge
Ref 00-589-009-000Model Boost 4 IVD Centrifuge
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 | Number081005286DDB4IVDTD 00810052865010 | Date8 Jun 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- Withdrawn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
- Boost 4 IVD Centrifuge, Drucker
- Model / Reference
- Boost 4 IVD Centrifuge, 00-589-009-000
- Primary DI / UDI-DI
- 00810052865010
- Basic UDI-DI
- 081005286DDB4IVDTD
- Direct Marketing DI
- 00810052865010
- EMDN Code
- W02069003 Centrifuges
- Device Class
- Class A
- EU market of registration
- Ireland
Manufacturer details
- EUDAMED SRN
- US-MF-000031517
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Drucker Diagnostics
Properties
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- New Device: No