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Dimension® CHEM I CAL 10716280

by Siemens Healthcare Diagnostics Inc.

Ref 10716280Model IVDR_67_GLA_DUB-C_C_REAG_Chemistry I Calibrator

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

CE IVDR

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/IVDR EUDAMED Number0405686901241V2 Basic UDI-DI 00630414948492UDI-DIDate17 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00630414948492 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.

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  • Withdrawn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 Chemistry I Calibrator EUDAMED
Dimension® CHEM I CAL GUDID
Generic Name
Multiple-type clinical chemistry analyte profile IVD, calibrator
Device Name
IVDR_67_GLA_DUB-C_C_REAG_Chemistry I Calibrator
Model / Ref / Catalog
10716280, IVDR_67_GLA_DUB-C_C_REAG_Chemistry I Calibrator, DC18C
Primary DI / UDI-DI
00630414948492
Basic UDI-DI
0405686901241V2
FDA Product Code
JJE, JIT
EMDN Code
W0101050301 Calibrators multicomponent (cc)
GMDN Term
Multiple-type clinical chemistry analyte profile IVD, calibrator
Device Class
Class C EUDAMED
Class I GUDID
Regulation Number
862.2160, 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 C
GUDID
Class I

Related devices

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

Other devices from Siemens Healthcare Diagnostics Inc.

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Properties

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

Other properties (18)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Human Tissues: No
  • Microbial Substances: 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