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Aptima HPV Assay Calibrators Kit
EUDAMEDClass C (EU MDR)
Ref 302554Ref 303093Ref 302929
by Hologic
Identity
- Trade Name
- Aptima HPV Assay Calibrators Kit EUDAMEDAptima HPV Assay EUDAMED
- Device Name
- Aptima HPV Assay EUDAMED
- Model / Reference
- 302554 EUDAMED303093 EUDAMED302929 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15420045509566 EUDAMED15420045509580 EUDAMED15420045509559 EUDAMED15420045509573 EUDAMED
- Basic UDI-DI
- 54200455DIAGAPTHPVBR EUDAMED
- Unit of Use DI
- 05420045509569 EUDAMED
- Direct Marketing DI
- 15420045509580 EUDAMED15420045509559 EUDAMED15420045509573 EUDAMED
- EMDN Code
- W0105080904 OTHER VIROLOGY STANDARDS AND CALIBRATORS - INF.IMM. EUDAMEDW0105041002 SCREENING HIGH-RISK HPV - NA REAGENTS EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Belgium 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
New Device
No
EUDAMED
Aptima HPV Assay Calibrators Kit is a reliable and accurate device for cervical cancer screening, ensuring high-quality test results with minimal user intervention. By providing comprehensive support and training for medical professionals, this kit helps ensure the reliability of diagnostic tests in clinical settings.
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 | 54200455DIAGAPTHPVBR | Class C | Active |
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Manufacturer
- Manufacturer
- Hologic
- EUDAMED SRN
- US-MF-000001646
- Authorised Representative
- Hologic BV BE-AR-000000127
Sources (4)
- EUDAMED 546142e2-08bc-47df-b11d-84bd9b3fd37b 61 fields · synced Aug 4, 2026
- EUDAMED 5de5e67d-52b0-426a-ac9d-78a69bf797b8 61 fields · synced Jul 9, 2026
- EUDAMED 1507304c-a7eb-4508-a1f4-c250f659ffce 61 fields · synced Jul 12, 2026
- EUDAMED 295125e4-f65f-4264-8044-7154fa32e1fa 61 fields · synced Aug 4, 2026