Identity
- Trade Name
- PATHFAST TB LAM Ag Control EUDAMED
- Device Name
- PATHFAST TB LAM Ag EUDAMED
- Model / Reference
- 30194 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987595301940 EUDAMED
- Basic UDI-DI
- 4987595PF1231KXJ EUDAMED
- EMDN Code
- W0105080899 CONTROLS - INF. IMMUNOLOGY - OTHER EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
PATHFAST TB LAM Ag Control by Phc Corporation — 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 | 4987595PF1231KXJ | Class C | Active |
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Manufacturer
- Manufacturer
- PHC Corporation
- EUDAMED SRN
- JP-MF-000008516
- Authorised Representative
- PHC Europe B.V. NL-AR-000002692
Sources (1)
- EUDAMED 317a072a-7f3f-4211-b2df-545d6d693704 61 fields · synced Jul 20, 2026