Identity
- Trade Name
- Aptima Transfer Solution EUDAMED
- Device Name
- Reagents and Fluids EUDAMED
- Model / Reference
- 303658 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15420045508606 EUDAMED
- Basic UDI-DI
- 54200455DIAGTRANSPORT6X EUDAMED
- Direct Marketing DI
- 15420045508606 EUDAMED
- EMDN Code
- W0105900201 BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC EUDAMED
Classification
- Device Class
- Class A 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 Transfer Solution by Hologic Inc. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 54200455DIAGTRANSPORT6X | Class A | Active |
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Manufacturer
- Manufacturer
- Hologic
- EUDAMED SRN
- US-MF-000001646
- Authorised Representative
- Hologic BV BE-AR-000000127
Sources (1)
- EUDAMED 14e6aa5e-5b9d-40af-b2e9-6ab79486770a 61 fields · synced Jul 8, 2026