Identity
- Trade Name
- PATHFAST EUDAMED
- Device Name
- PATHFAST EUDAMED
- Model / Reference
- 300929 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987595300929 EUDAMED
- Basic UDI-DI
- 4987595PATHFASTSC EUDAMED
- Direct Marketing DI
- 04987595300929 EUDAMED
- EMDN Code
- W0201069099 VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Pathfast by Phc Corporation — 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 | 4987595PATHFASTSC | Class A | Active |
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Manufacturer
- Manufacturer
- PHC Corporation
- EUDAMED SRN
- JP-MF-000008516
- Authorised Representative
- PHC Europe B.V. NL-AR-000002692
Sources (2)
- EUDAMED d845c260-e726-4894-9143-f3c5f2f7cf46 61 fields · synced Jul 12, 2026
- EUDAMED 0a808be6-64c4-4bce-9c95-2e15eb4a8c98 61 fields · synced Jul 12, 2026