LyoSens™
by Vitrosens Biotechnology Inc. 100 variants
Part of a family of 6 devices: see the family page
Ref LYO92WS24, PCR92
LyoSens™ (LYO92WS24) is a device classified as Class C (EU), IVD General (EU) made by Vitrosens Biotechnology Inc., registered in EUDAMED on 21 Aug 2026 (Basic UDI-DI 868511580PCR92JR), 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/IVDD | Number868511580PCR92JR 08684595037577 | Date21 Aug 2026 | StatusActive |
| European Union | CE/IVDR | Number868511580PCR92JR 08684595037577 | Date21 Aug 2026 | StatusActive |
Official records
- EUDAMED public site 868511580PCR92JR
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD, CE/IVDR Active
Specification
- Device name
- Dengue/Chikungunya/Zika Genotyping qPCR Kit
- Model / reference
- LYO92WS24, PCR92
- Primary DI / UDI-DI
- 08684595037577
- Basic UDI-DI
- 868511580PCR92JR, B-08684595037577
- EMDN code
- W0105070302 Other virus combinations - multiplex na reagents
- Device class
- Class CClass IVD General
- EU registration type
- Standard deviceLegacy device (under a directive)
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000026452
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