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BKIT VIRUS FINDER COVID-19 Saliva
EUDAMEDClass IVD General (EU MDR)
Ref bKTH-SCV2.04-72Model BKIT VIRUS FINDER COVID-19 Saliva
by Hyris Srl
Identity
- Trade Name
- BKIT VIRUS FINDER COVID-19 Saliva EUDAMED
- Device Name
- BKIT VIRUS FINDER COVID-19 Saliva EUDAMED
- Model / Reference
- BKIT VIRUS FINDER COVID-19 Saliva EUDAMEDbKTH-SCV2.04-72 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 80575074300852 EUDAMED
- Basic UDI-DI
- B-80575074300852 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 Saliva 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-80575074300852 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hyris Srl
- EUDAMED SRN
- IT-MF-000031635
Sources (1)
- EUDAMED 56c9c2a3-4c08-4698-9359-c8f84cc7ae96 61 fields · synced Jun 18, 2026