Identity
- Trade Name
- LyoSens HEV qPCR Kit EUDAMED
- Device Name
- HEV qPCR Kit EUDAMED
- Model / Reference
- PCR43 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08685115805478 EUDAMED
- Basic UDI-DI
- 868511580PCR43JC EUDAMED
- EMDN Code
- W0105020507 HEPATITIS E VIRUS - NA REAGENTS EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Türkiye 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
Yes
EUDAMED
New Device
No
EUDAMED
LyoSens HEV qPCR Kit by Vitrosens Biotechnology Inc. — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 868511580PCR43JC | Class C | Active |
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Manufacturer
- Manufacturer
- Vitrosens Biotechnology Inc.
- EUDAMED SRN
- TR-MF-000026452
Sources (1)
- EUDAMED 1c986cc2-1260-473e-95c1-23f2874a4701 61 fields · synced Jun 18, 2026