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Human Papillomavirus (HPV) Genotyping Detection Kit (Fluorescence PCR Method)
EUDAMEDClass IVD General (EU MDR)
Ref PR2026-HP04Model 8 samples/kit
Identity
- Device Name
- Human Papillomavirus (HPV) Genotyping Detection Kit (Fluorescence PCR Method) EUDAMED
- Model / Reference
- 8 samples/kit EUDAMEDPR2026-HP04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974541565677 EUDAMED
- Basic UDI-DI
- B-06974541565677 EUDAMED
- EMDN Code
- W0105041004 FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Cyprus 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
Human Papillomavirus (HPV) Genotyping Detection Kit (Fluorescence PCR Method) by Bioteke Corporation (Wuxi) Co., Ltd. — Class IVD General — IVDD — listed in…
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-06974541565677 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- BioTeke Corporation（Wuxi）Co., Ltd
- EUDAMED SRN
- CN-MF-000007517
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED e307ff24-09e1-4eb7-87d8-fde7f62c72b8 61 fields · synced Jul 9, 2026