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Dimension® Enzyme Verifier 10445016

by Siemens Healthcare Diagnostics Inc.

Ref 10445016Model IVDR_67_GLA_DUB-C_B_REAG_Enzyme Verifier

Dimension® Enzyme Verifier 10445016 (DC19) is a device classified as Class B in the EU and Class I in the US made by Siemens Healthcare Diagnostics Inc., registered in EUDAMED on 23 Jul 2026 (Basic UDI-DI 0405686901104UP) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00842768004988), 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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0405686901104UP Basic UDI-DI 00842768004988UDI-DIDate23 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00842768004988 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0405686901104UP registered 23 Jul 2026 Active
  • FDA GUDID UDI-DI 00842768004988 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00842768004988
  2. Registered EUDAMED 0405686901104UP

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  • Withdrawn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 Enzyme Verifier EUDAMED
Dimension® Enzyme Verifier GUDID
Generic name
Multiple clinical chemistry enzyme IVD, control
Device name
IVDR_67_GLA_DUB-C_B_REAG_Enzyme Verifier
Model / Ref / Catalog
10445016, IVDR_67_GLA_DUB-C_B_REAG_Enzyme Verifier, DC19
Primary DI / UDI-DI
00842768004988
Basic UDI-DI
0405686901104UP
Unit of use DI
00630414017129
FDA product code
JJE, JIT
EMDN code
W0101050301 Calibrators multicomponent (cc)
GMDN term
Multiple clinical chemistry enzyme IVD, control
Device class
Class B EUDAMED
Class I GUDID
Regulation number
862.2160, 862.1150
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 B
GUDID
Class I

Device class is stated on each registry's own scale: Class B 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: Multiple clinical chemistry enzyme IVD, control

Similar devices in this category

Other devices filed under CALIBRATORS MULTICOMPONENT (CC).

Other devices from Siemens Healthcare Diagnostics Inc.

See all devices from Siemens Healthcare Diagnostics Inc. →

Properties

  • Contains latex
  • Contains human tissues or cells
  • Contains animal tissues or cells
  • Reagent
  • Professional testing
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)