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Pathfast Sample Diluent 1

by PHC Corporation

Ref 30001

Pathfast Sample Diluent 1 (30001) is a device classified as Class A in the EU and Class II in the US made by Phc Corporation, registered in EUDAMED on 14 Mar 2023 (Basic UDI-DI 4987595PF01D6D) and listed in FDA GUDID since 18 Apr 2025 (UDI-DI 04987595300011), active as of 7 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE IVDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number04987595300011 UDI-DI Date18 Apr 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/IVDR EUDAMED Number4987595PF01D6D Basic UDI-DI 04987595300011UDI-DIDate14 Mar 2023RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4987595PF01D6D registered 14 Mar 2023 Active
  • FDA GUDID UDI-DI 04987595300011 listed 18 Apr 2025 Listed

Timeline

2 dated events

  1. Registered EUDAMED 4987595PF01D6D
  2. Listed FDA GUDID 04987595300011

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic name
Buffered sample diluent IVD
Model / reference
30001
Primary DI / UDI-DI
04987595300011
Basic UDI-DI
4987595PF01D6D
FDA product code
JIT
EMDN code
W01029003 Buffers (unassignable), supplem. reagents, etc (ic)
GMDN term
Buffered sample diluent IVD
Device class
Class A EUDAMED
Class II GUDID
Regulation number
862.1150
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class A
GUDID
Class II

Device class is stated on each registry's own scale: Class A in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
JP-MF-000008516
Authorised representative
PHC Europe B.V. NL-AR-000002692

Similar devices in this category

Other devices filed under BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC).

Other devices from Phc Corporation

See all devices from Phc Corporation →

Properties

  • Reagent
  • Professional testing
  • Lot / batch number
  • Expiration date
Other properties (22, all answered No)