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High-Risk Human Papillomavirus (HPV) Nucleic Acid Detection Kit (PCR-Fluorescen…
EUDAMEDClass IVD General (EU MDR)
Ref W-HPV14-A-48Model AP1, 48 tests/box
Identity
- Trade Name
- High-Risk Human Papillomavirus (HPV) Nucleic Acid Detection Kit (PCR-Fluorescence Probing) EUDAMED
- Device Name
- High-Risk Human Papillomavirus (HPV) Nucleic Acid Detection Kit (PCR-Fluorescence Probing) EUDAMED
- Model / Reference
- AP1, 48 tests/box EUDAMEDW-HPV14-A-48 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978896417513 EUDAMED
- Basic UDI-DI
- B-06978896417513 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
High-Risk Human Papillomavirus (HPV) Nucleic Acid Detection Kit (PCR-Fluorescen… by Wuhan Easydiagnosis Biomedicine Co., Ltd. — Class IVD General — CE/MDR…
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06978896417513 | 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 (1)
- EUDAMED 983eb07c-b301-41cc-8cfa-21e7596b8921 61 fields · synced Oct 6, 2026