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Dimension Vista T4/TU CAL 11319105

by Siemens Healthcare Diagnostics Inc.

Ref 11319105Model DX_LS_LEGACY_00630414240268

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

CE IVDD

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-00630414240268 Basic UDI-DI 00630414240268UDI-DIDate25 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00630414240268 UDI-DI Date24 Jan 2021ListedStatusListed 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.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Dimension Vista Thyroxine/Thyronine-Uptake Calibrator (T4/TU CAL) EUDAMED
Dimension Vista T4/TU CAL GUDID
Generic Name
Multiple-type clinical chemistry analyte profile IVD, calibrator
Device Name
DX_LS_LEGACY_00630414240268
Model / Ref / Catalog
11319105, DX_LS_LEGACY_00630414240268, KC165
Primary DI / UDI-DI
00630414240268
Basic UDI-DI
B-00630414240268
FDA Product Code
JIX
EMDN Code
W0101050301 Calibrators multicomponent (cc)
GMDN Term
Multiple-type clinical chemistry analyte profile IVD, calibrator
Device Class
Class IVD General 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 IVD General
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

  • Human Tissues
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (16)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: 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
  • Serial Number: No
  • Manufacturing Date: No