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Bkit Virus Finder Covid-19
EUDAMEDClass IVD General (EU MDR)
Ref bKTH-SCV2.02-72Model BKIT VIRUS FINDER COVID-19Ref bKTH-SCV2.02-32
by Hyris Srl
Identity
- Trade Name
- BKIT VIRUS FINDER COVID-19 EUDAMED
- Device Name
- BKIT VIRUS FINDER COVID-19 EUDAMED
- Model / Reference
- BKIT VIRUS FINDER COVID-19 EUDAMEDbKTH-SCV2.02-72 EUDAMEDbKTH-SCV2.02-32 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 80575074300616 EUDAMED80575074300548 EUDAMED
- Basic UDI-DI
- B-80575074300616 EUDAMEDB-80575074300548 EUDAMED
- EMDN Code
- W0105040519 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Bkit Virus Finder Covid-19 by Hyris Srl — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-80575074300616 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hyris Srl
- EUDAMED SRN
- IT-MF-000031635
Sources (2)
- EUDAMED f60d35c6-4c5b-48cd-bb03-b8fa762ea944 61 fields · synced Jul 20, 2026
- EUDAMED 7c0d8e2a-8655-407c-b8fc-4d0a79c23d0f 61 fields · synced May 16, 2026