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High-risk HPV genotyping real-time PCR detection kit
EUDAMEDClass IVD General (EU MDR)
Ref 13787-2Model PV02-1Y24
Identity
- Trade Name
- High-risk HPV genotyping real-time PCR detection kit EUDAMED
- Device Name
- High-risk HPV genotyping real-time PCR detection kit EUDAMED
- Model / Reference
- PV02-1Y24 EUDAMED13787-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974689627190 EUDAMED
- Basic UDI-DI
- B-06974689627190 EUDAMED
- EMDN Code
- W0105041003 PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
Yes
EUDAMED
Surgical Instrument
Yes
EUDAMED
High-risk HPV genotyping 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-06974689627190 | 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 (1)
- EUDAMED 38dd82cf-5ac2-4ac3-95d5-a52af96534cc 61 fields · synced Jun 18, 2026