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Fluid pack

by Diamond Diagnostics Inc 8 variants

Ref ME-2123D

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, self-declared

Class I: no certifier involved

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 Number081140301ME2123DDD Basic UDI-DI 00811403015917UDI-DIDate22 May 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00811403015917 UDI-DI Date5 Jun 2023ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

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  • Withdrawn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
Fluid pack EUDAMED
Pack, 800mL, Na/K/Ca/pH GUDID
Generic Name
Multiple blood gas analyte IVD, control
Device Name
Fluid Pack Eastlyte Na-K-Ca-pH
Model / Reference
ME-2123D
Primary DI / UDI-DI
00811403015917
Basic UDI-DI
081140301ME2123DDD
FDA Product Code
JIT
EMDN Code
W0101050399 Calibrators and standards (clinical chemistry) - other
GMDN Term
Multiple blood gas analyte IVD, control
Device Class
Class A EUDAMED
Class II GUDID
Regulation Number
862.1150
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

  • Single Use
  • Reagent
  • Professional Testing
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

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