OSOM® Mono Test
Ref 145
OSOM® Mono Test (145) is a device classified as IVD General made by Sekisui Diagnostics, LLC, registered in EUDAMED on 7 Sep 2026 (Basic UDI-DI B-145_CV), active as of 24 Oct 2026.
Active
CE IVDD
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-145_CV D-145_CV | Date7 Sep 2026 | StatusActive |
Official records
- EUDAMED public site B-145_CV
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- Withdrawn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/IVDD Active
Specification
- Model / reference
- 145
- Primary DI / UDI-DI
- D-145_CV
- Basic UDI-DI
- B-145_CV
- EMDN code
- W0105099003 Mononucleosis (ebv) - rt & poc
- Device class
- Class IVD General
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- US-MF-000025170
- Authorised representative
- MDSS GmbH DE-AR-000005430
From the manufacturer
Manufacturer's product page: OSOM®
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