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Atellica CH Crea3 11537567

by Siemens Healthcare Diagnostics Inc.

Ref 11537567Model IVDR_67_LLB_DUB-C_C_REAG_Crea3

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 Number0405686902344VL Basic UDI-DI 00630414653259UDI-DIDate18 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00630414653259 UDI-DI Date8 May 2026ListedStatusListed 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  • Withdrawn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
Atellica CH Creatinine 3 (Crea3) EUDAMED
Atellica CH Crea3 GUDID
Generic Name
Creatinine IVD, kit, spectrophotometry
Device Name
IVDR_67_LLB_DUB-C_C_REAG_Crea3
Model / Ref / Catalog
11537567, IVDR_67_LLB_DUB-C_C_REAG_Crea3
Primary DI / UDI-DI
00630414653259
Basic UDI-DI
0405686902344VL
Unit of Use DI
00630414321820
FDA Product Code
CGX
EMDN Code
W01010207 Creatinine
GMDN Term
Creatinine IVD, kit, spectrophotometry
Device Class
Class C EUDAMED
Class II GUDID
Regulation Number
862.1225
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 II

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Properties

  • Reagent
  • Professional Testing
  • Lot / Batch Number
  • Expiration Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Animal 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