Identity
- Trade Name
- PATHFAST SAMPLE DILUENT 1 EUDAMEDFDA UDI
- Generic Name
- Buffered sample diluent IVD FDA UDI
- Device Name
- PATHFAST SAMPLE DILUENT 1 EUDAMED
- Model / Reference
- 30001 EUDAMEDN/A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987595300011 EUDAMEDFDA UDI
- Basic UDI-DI
- 4987595PF01D6D EUDAMED
- FDA Product Code
- JIT FDA UDI
- EMDN Code
- W01029003 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC) EUDAMED
- GMDN Term
- Buffered sample diluent IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1150 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Pathfast Sample Diluent 1 by Phc Corporation — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 4987595PF01D6D | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- PHC Corporation
- EUDAMED SRN
- JP-MF-000008516
- Authorised Representative
- PHC Europe B.V. NL-AR-000002692
Sources (3)
- EUDAMED 75edfaf5-4bf2-4d97-b960-a863897287a9 61 fields · synced Jul 12, 2026
- FDA UDI 15e48fb3-445a-421a-b09b-f7a800c0a320 32 fields · synced May 30, 2026
- EUDAMED fe35579a-a86d-46b1-a430-d24093e5a836 61 fields · synced Jul 12, 2026