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Probe

by Diamond Diagnostics Inc 2 variants

Ref AW-402377D

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

CE IVDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number081140301AW402377DJE Basic UDI-DI 00811403018765UDI-DIDate10 May 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00811403018765 UDI-DI Date10 Jun 2023ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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

Trade Name
Probe EUDAMED
Sample Probe GUDID
Generic Name
Ion-selective analyser IVD
Model / Reference
AW-402377D
Primary DI / UDI-DI
00811403018765
Basic UDI-DI
081140301AW402377DJE
EMDN Code
W05020180 Samples transport, containers - accessories
GMDN Term
Ion-selective analyser IVD
Device Class
Class A
EU market of registration
Hungary
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
US-MF-000035435
Authorised representative
Diamond Diagnostics Inc. Magyarországi Fióktelepe HU-AR-000034351

Other devices from DIAMOND DIAGNOSTICS Inc

See all devices from DIAMOND DIAGNOSTICS Inc →

Properties

  • Professional Testing
  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No