Identity
- Trade Name
- LyoSens HBV Detection qPCR Kit EUDAMED
- Device Name
- HBV Detection qPCR Kit EUDAMED
- Model / Reference
- LYO78 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08684595034897 EUDAMED
- Basic UDI-DI
- B-08684595034897 EUDAMED
- EMDN Code
- W0105020299 HBV REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
Yes
EUDAMED
Surgical Instrument
Yes
EUDAMED
LyoSens HBV Detection qPCR Kit by Vitrosens Biotechnology Inc. — 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-08684595034897 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Vitrosens Biotechnology Inc.
- EUDAMED SRN
- TR-MF-000026452
Sources (1)
- EUDAMED f4cd85ec-9491-4530-84c5-48884d340cd3 61 fields · synced Jun 20, 2026