Identity
- Trade Name
- LyoSens Norovirus GI EUDAMED
- Device Name
- Norovirus GI Detection qPCR Kit EUDAMED
- Model / Reference
- LYO14 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683548258687 EUDAMED
- Basic UDI-DI
- B-08683548258687 EUDAMED
- EMDN Code
- W0105040516 NOROVIRUS - NA REAGENTS 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 Norovirus GI 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-08683548258687 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Vitrosens Biotechnology Inc.
- EUDAMED SRN
- TR-MF-000026452
Sources (1)
- EUDAMED 99b6c0c8-4dc3-4378-9f2f-ef3ddf7ad766 61 fields · synced Jun 18, 2026