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Flush solution

by Diamond Diagnostics Inc

Ref ME-2309D

Flush solution (ME-2309D) is a device classified as Class A in the EU and Class II in the US made by DIAMOND DIAGNOSTICS Inc, registered in EUDAMED on 22 May 2024 (Basic UDI-DI 081140301ME2309DE3) and listed in FDA GUDID since 5 Jun 2023 (UDI-DI 00811403015955), active as of 22 Oct 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, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number081140301ME2309DE3 Basic UDI-DI 00811403015955UDI-DIDate22 May 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00811403015955 UDI-DI Date5 Jun 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081140301ME2309DE3 registered 22 May 2024 Active
  • FDA GUDID UDI-DI 00811403015955 listed 5 Jun 2023 Listed

Certificates

0 certificates · EUDAMED

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

Timeline

2 dated events

  1. Listed FDA GUDID 00811403015955
  2. Registered EUDAMED 081140301ME2309DE3

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  • Withdrawn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
Multiple electrolyte IVD, reagent
Model / reference
ME-2309D
Primary DI / UDI-DI
00811403015955
Basic UDI-DI
081140301ME2309DE3
FDA product code
CGZ, CEM, JGS, JFL
EMDN code
W01019099 Clinical chemistry reagents - other
GMDN term
Multiple electrolyte IVD, reagent
Device class
Class A EUDAMED
Class II GUDID
Regulation number
862.1170, 862.1600, 862.1665, 862.1160
EU registration type
Standard device
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

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

Related devices

Category: Nucleic acid extraction/isolation kit IVD

Similar devices in this category

Other devices filed under CLINICAL CHEMISTRY REAGENTS - OTHER.

Other devices from DIAMOND DIAGNOSTICS Inc

See all devices from DIAMOND DIAGNOSTICS Inc →

Properties

  • Single use
  • Reagent
  • Professional testing
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)