← Back to catalogue
LyoSens Atypical CAP Panel Genotyping qPCR Kit
EUDAMEDClass IVD General (EU MDR)
Ref LYO129Model LYO129WS96
Identity
- Trade Name
- LyoSens Atypical CAP Panel Genotyping qPCR Kit EUDAMED
- Device Name
- Atypical CAP Panel Genotyping qPCR Kit EUDAMED
- Model / Reference
- LYO129WS96 EUDAMEDLYO129 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08685115805003 EUDAMED
- Basic UDI-DI
- B-08685115805003 EUDAMED
- EMDN Code
- W0105070503 RESPIRATORY TRACT INFECTIONS - MULTIPLEX 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
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
Yes
EUDAMED
Surgical Instrument
Yes
EUDAMED
LyoSens Atypical CAP Panel Genotyping 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-08685115805003 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Vitrosens Biotechnology Inc.
- EUDAMED SRN
- TR-MF-000026452
Sources (1)
- EUDAMED df172e6d-70bd-424f-97c6-ee109b079ea7 61 fields · synced Oct 7, 2026