LyoSens™
by Vitrosens Biotechnology Inc. 125 variants
Ref PCR56, LYO56WS96, LYO56WS24Model LYO56WS48
LyoSens™ (PCR56) is a device classified as IVD General (EU), Class C (EU) made by Vitrosens Biotechnology Inc., registered in EUDAMED on 24 Jul 2026 (Basic UDI-DI B-08684998276788), active as of 24 Oct 2026.
Active
CE IVDR CE IVDD
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | NumberB-08684998276788 | Date24 Jul 2026 | StatusActive |
| European Union | CE/IVDD | NumberB-08684998276788 | Date24 Jul 2026 | StatusActive |
Official records
- EUDAMED public site B-08684998276788
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR, CE/IVDD Active
Specification
- Device name
- Mycoplasma hominis qPCR Kit
- Model / reference
- LYO56WS48, PCR56, LYO56WS96, LYO56WS24
- Primary DI / UDI-DI
- 08684998276788, 08684998276825, 08684998276740
- Basic UDI-DI
- B-08684998276788, 868499827PCR56Y4, B-08684998276825, B-08684998276740
- EMDN code
- W010501080302 Urogenital mycoplasma detection by na reagents
- Device class
- Class IVD GeneralClass C
- EU registration type
- Legacy device (under a directive)Standard device
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000026452
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