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Qnostics Ltd
EUDAMEDClass IVD General (EU MDR)
Ref BKVAQP02-AModel BK Virus (BKV) Analytical Q Panel
Identity
- Trade Name
- Qnostics Ltd EUDAMED
- Model / Reference
- BK Virus (BKV) Analytical Q Panel EUDAMEDBKVAQP02-A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060605500195 EUDAMED
- Basic UDI-DI
- B-05060605500195 EUDAMED
- EMDN Code
- W0105080808 ALL INFECTIOUS DISEASES CONTROLS - NAT EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
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
Qnostics Ltd by Qnostics Ltd. — 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-05060605500195 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Qnostics Ltd.
- EUDAMED SRN
- UK-MF-000047352
- Authorised Representative
- WMDE B.V. NL-AR-000002062
Sources (1)
- EUDAMED 02938bdf-c667-4157-ad90-939d5a150cb4 61 fields · synced Jun 18, 2026