Identity
- Trade Name
- PATHFAST SAMPLE DILUENT 2 EUDAMEDFDA UDI
- Generic Name
- Buffered sample diluent IVD FDA UDI
- Device Name
- PATHFAST SAMPLE DILUENT 2 EUDAMED
- Model / Reference
- 30002 EUDAMEDN/A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987595300028 EUDAMEDFDA UDI
- Basic UDI-DI
- 4987595PF02D6G 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
Yes
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 2 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 | 4987595PF02D6G | 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 ba3caf0d-0972-4364-89b2-ae6af903e965 61 fields · synced Jul 27, 2026
- FDA UDI 53b149dc-e318-4543-8b7f-d5edd19ac480 32 fields · synced May 30, 2026
- EUDAMED 067997f1-ed83-48d2-9906-54b313511424 61 fields · synced Jul 27, 2026