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HPV nucleic acid real-time PCR detection kit
EUDAMEDClass IVD General (EU MDR)
Ref "Model: PV01-2Y32; Specification: 32 Tests Model: PV01-1Y32; Specification: 32 Tests"Model PV01-2Y32; PV01-1Y32;Ref 13778-1Model PV01-2Y32
Identity
- Trade Name
- HPV nucleic acid real-time PCR detection kit EUDAMED
- Device Name
- HPV nucleic acid real-time PCR detection kit EUDAMED
- Model / Reference
- PV01-2Y32; PV01-1Y32; EUDAMED"Model: PV01-2Y32; Specification: 32 Tests Model: PV01-1Y32; Specification: 32 Tests" EUDAMEDPV01-2Y32 EUDAMED13778-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974689626056 EUDAMED
- Basic UDI-DI
- B-06974689626056 EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - OTHER EUDAMEDW0105041003 PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS 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
HPV 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-06974689626056 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- TargetingOne Technology (Beijing) Corporation
- EUDAMED SRN
- CN-MF-000028247
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (4)
- EUDAMED 44f76c13-7ea1-478b-aca4-caa5cba48b17 61 fields · synced Jun 18, 2026
- EUDAMED 44f76c13-7ea1-478b-aca4-caa5cba48b17-1 61 fields · synced Jun 9, 2026
- EUDAMED 44f76c13-7ea1-478b-aca4-caa5cba48b17-2 61 fields · synced Jun 9, 2026
- EUDAMED 5932d038-0455-4260-93ec-f02b400ae1bb 61 fields · synced Jun 18, 2026