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Dimension® Sample Probe Cleaner 10445035

by Siemens Healthcare Diagnostics Inc.

Ref 10445035Model IVDR_67_GLA_DUB-C_A_REAG_Sample Probe Cleaner

Dimension Sample Probe Cleaner 10445035 (RD703) is a wash/cleaning solution IVD (EU IVDR Class A; FDA Class I) made by Siemens Healthcare Diagnostics Inc., registered in EUDAMED on 8 Jul 2026 (Basic UDI-DI 0405686901041UQ) and listed in FDA GUDID since 24 Sep 2020 (UDI-DI 00842768013775), active as of 24 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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0405686901041UQ Basic UDI-DI 00842768013775UDI-DIDate8 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00842768013775 UDI-DI Date24 Sep 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0405686901041UQ registered 8 Jul 2026 Active
  • FDA GUDID UDI-DI 00842768013775 listed 24 Sep 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00842768013775
  2. Registered EUDAMED 0405686901041UQ

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  • Withdrawn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
Dimension® Sample Probe Cleaner
Generic name
Wash/cleaning solution IVD, automated/semi-automated system
Device name
IVDR_67_GLA_DUB-C_A_REAG_Sample Probe Cleaner
Model / Ref / Catalog
10445035, IVDR_67_GLA_DUB-C_A_REAG_Sample Probe Cleaner, RD703
Primary DI / UDI-DI
00842768013775
Basic UDI-DI
0405686901041UQ
FDA product code
JJE, JMG
EMDN code
W0201020185 Automated immunochemistry analysers - consumables
GMDN term
Wash/cleaning solution IVD, automated/semi-automated system
Device class
Class A EUDAMED
Class I GUDID
Regulation number
862.2160, 866.5340
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class A
GUDID
Class I

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

Related devices

Category: Wash/cleaning solution IVD, automated/semi-automated system

Similar devices in this category

Other devices filed under AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES.

Other devices from Siemens Healthcare Diagnostics Inc.

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Properties

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