← Back to catalogue
Monkeypox virus nucleic acid real-time PCR detection kit
EUDAMEDClass IVD General (EU MDR)
Ref MV01-2Y32; MV01-1Y32; MV02-Y32; Model MV01-2Y32;MV01-1Y32;MV02-Y32;Ref 13802Model MV02-Y32Model MV01-2Y32Ref 13801Model MV01-1Y32
Identity
- Trade Name
- Monkeypox virus nucleic acid real-time PCR detection kit EUDAMED
- Device Name
- Monkeypox virus nucleic acid real-time PCR detection kit EUDAMED
- Model / Reference
- MV01-2Y32;MV01-1Y32;MV02-Y32; EUDAMEDMV01-2Y32; MV01-1Y32; MV02-Y32; EUDAMEDMV02-Y32 EUDAMED13802 EUDAMEDMV01-2Y32 EUDAMEDMV01-1Y32 EUDAMED13801 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974689626513 EUDAMED06974689627220 EUDAMED06974689627213 EUDAMED
- Basic UDI-DI
- B-06974689626513 EUDAMEDB-06974689627220 EUDAMEDB-06974689627213 EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - OTHER EUDAMEDW01050499 VIROLOGY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Finland EUDAMEDAustria 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
Monkeypox virus nucleic acid real-time PCR detection kit by TargetingOne Technology (Beijing) Corporation — Class IVD General — IVDD — listed in EUDAMED
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-06974689626513 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- TargetingOne Technology (Beijing) Corporation
- EUDAMED SRN
- CN-MF-000028247
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (5)
- EUDAMED 39c055ec-d163-4d1f-9f48-4a8e39ede194 61 fields · synced Aug 1, 2026
- EUDAMED 39c055ec-d163-4d1f-9f48-4a8e39ede194-1 61 fields · synced Jun 9, 2026
- EUDAMED 44bf464d-5ca4-47aa-b584-40200e5365b4 61 fields · synced Jul 13, 2026
- EUDAMED 2d6a4185-8b4a-4b6d-b3d6-672a8e9487a2-1 61 fields · synced Jul 28, 2026
- EUDAMED 6397cdaf-9b8e-4b53-a0eb-bbae3bb613c8 61 fields · synced Jul 28, 2026