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Human Papillomavirus (HPV) Nucleic Acid Detection and Genotyping Kit (PCR-Multi…
EUDAMEDClass IVD General (EU MDR)
Ref W-HPV18FX-A-48Model 48 Tests/KitRef W-HPV18FX-A-24Model 24 Tests/KitRef W-HPV18FX-A-96Model 96 Tests/Kit
Identity
- Trade Name
- Human Papillomavirus (HPV) Nucleic Acid Detection and Genotyping Kit (PCR-Multiplex Probe Melting Curve Method) EUDAMED
- Device Name
- Human Papillomavirus (HPV) Nucleic Acid Detection and Genotyping Kit (PCR-Multiplex Probe Melting Curve Method) EUDAMED
- Model / Reference
- 48 Tests/Kit EUDAMEDW-HPV18FX-A-48 EUDAMED24 Tests/Kit EUDAMEDW-HPV18FX-A-24 EUDAMED96 Tests/Kit EUDAMEDW-HPV18FX-A-96 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978896417483 EUDAMED06978896417476 EUDAMED06978896417490 EUDAMED
- Basic UDI-DI
- B-06978896417483 EUDAMEDB-06978896417476 EUDAMEDB-06978896417490 EUDAMED
- EMDN Code
- W0105041099 HPV REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Romania 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Human Papillomavirus (HPV) Nucleic Acid Detection and Genotyping Kit (PCR-Multi… by Wuhan Easydiagnosis Biomedicine Co., Ltd. — Class IVD General — IVDD…
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-06978896417483 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Wuhan Easydiagnosis Biomedicine Co., Ltd.
- EUDAMED SRN
- CN-MF-000019908
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (3)
- EUDAMED 2255e31e-80a4-447e-96c8-876114be4000 61 fields · synced Oct 6, 2026
- EUDAMED cff84c7e-164d-446c-899b-c95d323ea7cc 61 fields · synced May 18, 2026
- EUDAMED d333dca4-d6a9-48d5-9936-57265c3473d6 61 fields · synced May 18, 2026