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Dimension® Thyroid Calibrator 10445018

by Siemens Healthcare Diagnostics Inc.

Ref 10445018Model IVDR_67_GLA_DUB-C_B_REAG_THY CAL

Active European Union. Also listed in GUDID (US).

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

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 Number0405686901198VS Basic UDI-DI 00842768013683UDI-DIDate23 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00842768013683 UDI-DI Date24 Sep 2016ListedStatusListed 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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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 Thyroid Calibrator EUDAMED
Dimension® Thyroid Calibrator GUDID
Generic Name
Multiple-type clinical chemistry analyte profile IVD, calibrator
Device Name
IVDR_67_GLA_DUB-C_b_reag_thy Cal
Model / Ref / Catalog
10445018, IVDR_67_GLA_DUB-C_B_REAG_THY CAL, RC410
Primary DI / UDI-DI
00842768013683
Basic UDI-DI
0405686901198VS
Unit of Use DI
00630414017143
510(k) Number
FDA Product Code
JIT
EMDN Code
W01020499 Thyroid hormones - other
GMDN Term
Multiple-type clinical chemistry analyte profile IVD, calibrator
Device Class
Class B EUDAMED
Class II GUDID
Regulation Number
862.1150
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 II

Related devices

Category: Multiple-type clinical chemistry analyte profile IVD, calibrator

Other devices from Siemens Healthcare Diagnostics Inc.

See all devices from Siemens Healthcare Diagnostics Inc. →

Properties

  • Contains Latex
  • Human Tissues
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
  • Lot / Batch Number
  • Expiration Date

Other properties (16)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No