Identity
- Trade Name
- Panther Fusion MRSA Assay EUDAMED
- Device Name
- Panther Fusion MRSA Assay EUDAMED
- Model / Reference
- PRD-04803 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15420045510401 EUDAMED
- Basic UDI-DI
- 54200455DIAGPFMRSADE EUDAMED
- Unit of Use DI
- 05420045510404 EUDAMED
- EMDN Code
- W0105011203 STAPHYLOCOCCAL DETECTION BY 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
Panther Fusion MRSA Assay by Hologic Inc. — Class C — 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 | 54200455DIAGPFMRSADE | Class C | Active |
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Manufacturer
- Manufacturer
- Hologic
- EUDAMED SRN
- US-MF-000001646
- Authorised Representative
- Hologic BV BE-AR-000000127
Sources (1)
- EUDAMED 43021e1e-27c9-4a20-b856-0691cca2ce6b 61 fields · synced Jun 18, 2026