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Qnostics Ltd
EUDAMEDClass IVD General (EU MDR)
Ref ADVAQP01-AModel Adenovirus (ADV) Analytical Q PanelRef BKVMQP01-AModel BK Virus (BKV) Molecular Q PanelRef HSV2MQC01-AModel Herpes Simplex Virus 2 (HSV2) Molecular Q ControlRef HSV2AQP02-AModel Herpes Simplex Virus 2 (HSV2) Analytical Q PanelRef EBVMQP01-AModel Epstein-Barr Virus (EBV) Molecular Q PanelRef ADVMQC01-AModel Adenovirus (ADV) Molecular Q ControlRef EBVAQP03-AModel Epstein-Barr Virus (EBV) Analytical Q Panel
Identity
- Trade Name
- Qnostics Ltd EUDAMED
- Model / Reference
- Adenovirus (ADV) Analytical Q Panel EUDAMEDADVAQP01-A EUDAMEDBK Virus (BKV) Molecular Q Panel EUDAMEDBKVMQP01-A EUDAMEDHerpes Simplex Virus 2 (HSV2) Molecular Q Control EUDAMEDHSV2MQC01-A EUDAMEDHerpes Simplex Virus 2 (HSV2) Analytical Q Panel EUDAMEDHSV2AQP02-A EUDAMEDEpstein-Barr Virus (EBV) Molecular Q Panel EUDAMEDEBVMQP01-A EUDAMEDAdenovirus (ADV) Molecular Q Control EUDAMEDADVMQC01-A EUDAMEDEpstein-Barr Virus (EBV) Analytical Q Panel EUDAMEDEBVAQP03-A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060605500119 EUDAMED05060605500218 EUDAMED05060605500645 EUDAMED05060605500591 EUDAMED05060605500331 EUDAMED05060605500164 EUDAMED05060605500317 EUDAMED
- Basic UDI-DI
- B-05060605500119 EUDAMEDB-05060605500218 EUDAMEDB-05060605500645 EUDAMEDB-05060605500591 EUDAMEDB-05060605500331 EUDAMEDB-05060605500164 EUDAMEDB-05060605500317 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
Yes
EUDAMEDEUDAMED
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-05060605500119 | 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 (7)
- EUDAMED f7e96070-e135-451f-b11a-52dddab05a40 61 fields · synced Jul 26, 2026
- EUDAMED 407d55ec-fd81-4526-ba0a-6f3a4400d2a2 61 fields · synced Jul 9, 2026
- EUDAMED 24ef6580-c28f-4df0-8472-cf7269f00025 61 fields · synced Jul 13, 2026
- EUDAMED fc0b9db1-93c4-4d2b-967c-58ac17304ea0 61 fields · synced Jul 16, 2026
- EUDAMED 91a7b10f-e52d-48e6-a5b7-13044d737e5e 61 fields · synced Jul 18, 2026
- EUDAMED b97f371c-00aa-424c-81cb-3d0485db4cb4 61 fields · synced Jul 20, 2026
- EUDAMED 543712bb-452e-48ee-bd57-a3826e976e64 61 fields · synced Jul 26, 2026