ChainFor™
by Vitrosens Biotechnology Inc. 134 variants
Ref PCR186, CFP186P50Model CFP186P25, CFP186P100
ChainFor™ (PCR186) is a device classified as IVD General (EU), Class C (EU) made by Vitrosens Biotechnology Inc., registered in EUDAMED on 19 Aug 2026 (Basic UDI-DI B-08685214529299), active as of 25 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-08685214529299 | Date19 Aug 2026 | StatusActive |
| European Union | CE/IVDD | NumberB-08685214529299 | Date19 Aug 2026 | StatusActive |
Official records
- EUDAMED public site B-08685214529299
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR, CE/IVDD Active
Specification
- Device name
- Cryptococcus gatti/neoformans qPCR Kit
- Model / reference
- CFP186P25, PCR186, CFP186P50, CFP186P100
- Primary DI / UDI-DI
- 08685214529299, 08685214529305, 08685214529329
- Basic UDI-DI
- B-08685214529299, 868521452PCR186GQ, B-08685214529329, B-08685214529305
- EMDN code
- W0105060303 Cryptococcus
- 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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