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LyoSens H.pylori/Clarithromycin Genotyping qPCR Kit
EUDAMEDClass IVD General (EU MDR)
Ref LYO144Model LYO144WS96Ref PCR144
Identity
- Trade Name
- LyoSens H.pylori/Clarithromycin Genotyping qPCR Kit EUDAMEDLyoSens™ EUDAMED
- Device Name
- H.pylori/Clarithromycin Genotyping qPCR Kit EUDAMED
- Model / Reference
- LYO144WS96 EUDAMEDLYO144 EUDAMEDPCR144 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08685115807519 EUDAMED
- Basic UDI-DI
- B-08685115807519 EUDAMED868511580PCR144GP EUDAMED
- EMDN Code
- W0105010403 H. PYLORI DETECTION BY NA REAGENTS EUDAMEDW0105050399 OTHER PARASITOLOGY - NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass C EUDAMED
- Market of Registration
- Germany EUDAMEDTürkiye 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
New Device
No
EUDAMED
LyoSens H.pylori/Clarithromycin Genotyping qPCR Kit by Vitrosens Biotechnology Inc. — Class IVD General — IVDR, IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-08685115807519 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-08685115807519 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Vitrosens Biotechnology Inc.
- EUDAMED SRN
- TR-MF-000026452
Sources (3)
- EUDAMED 29af6d05-5b07-4f5d-b8b1-7a821f7c8a75 61 fields · synced Oct 7, 2026
- EUDAMED c1286954-7808-4131-bc93-e1589974a16d 61 fields · synced Oct 7, 2026
- EUDAMED 4ad1e23c-ae02-443c-b0f7-8e436c07dad6 61 fields · synced Oct 7, 2026