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Electrode

by Diamond Diagnostics Inc 38 variants

Ref BM-371037D

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 Number081140301BM371037DDV Basic UDI-DI 00811403012541UDI-DIDate10 May 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00811403012541 UDI-DI Date12 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  • Withdrawn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
Electrode EUDAMED
Sodium Electrode GUDID
Generic Name
Sodium (Na+) electrode IVD
Device Name
Na+ Electrode
Model / Reference
BM-371037D
Primary DI / UDI-DI
00811403012541
Basic UDI-DI
081140301BM371037DDV
FDA Product Code
JGS
EMDN Code
W0580 IVD general use consumables devices - other accessories
GMDN Term
Sodium (Na+) electrode IVD
Device Class
Class A EUDAMED
Class II GUDID
Regulation Number
862.1665
EU market of registration
Hungary
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class A
GUDID
Class II

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
  • Prescription Use
  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Expiration Date

Other properties (17)

  • 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
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Manufacturing Date: No