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High-risk HPV genotyping real-time PCR detection kit

EUDAMED

Class IVD General (EU MDR)

Ref "Model: PV02-2Y24; Specification: 24 Tests Model: PV02-1Y24; Specification: 24 Tests"Model PV02-2Y24,PV02-1Y24Model PV02-2Y24

by TargetingOne Technology (Beijing) Corporation

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
PV02-2Y24,PV02-1Y24 EUDAMED
"Model: PV02-2Y24; Specification: 24 Tests Model: PV02-1Y24; Specification: 24 Tests" EUDAMED
PV02-2Y24 EUDAMED

Identifiers

Primary DI / UDI-DI
06974689626360 EUDAMED
Basic UDI-DI
B-06974689626360 EUDAMED
EMDN Code
W0105041099 HPV REAGENTS - OTHER EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Finland 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

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

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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 (3)

  • EUDAMED aa4237b5-1106-42e1-99dd-999b103d63c0 61 fields · synced Jun 18, 2026
  • EUDAMED aa4237b5-1106-42e1-99dd-999b103d63c0-1 61 fields · synced Jun 10, 2026
  • EUDAMED 9a001920-ad2a-442f-9779-5d95a1ac097c-1 61 fields · synced Jun 18, 2026