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Atellica CH Billirubin Calibrator (BILI CAL) 11537243

by Siemens Healthcare Diagnostics Inc.

Ref 11537243Model IVDR_67_TTN_DUB-C_C_REAG_BILI CAL

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 Number0405686902241V9 Basic UDI-DI 00630414615097UDI-DIDate15 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00630414615097 UDI-DI Date3 Apr 2024ListedStatusListed 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  • Withdrawn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 Bilirubin Calibrator (BILI CAL) EUDAMED
Atellica CH Billirubin Calibrator (BILI CAL) GUDID
Generic Name
Multiple-type clinical chemistry analyte profile IVD, calibrator
Device Name
IVDR_67_TTN_DUB-C_c_reag_bili Cal
Model / Ref / Catalog
11537243, IVDR_67_TTN_DUB-C_C_REAG_BILI CAL
Primary DI / UDI-DI
00630414615097
Basic UDI-DI
0405686902241V9
Unit of Use DI
00630414313450
FDA Product Code
JIS, JIX
EMDN Code
W0101050302 Calibrators single component (cc)
GMDN Term
Multiple-type clinical chemistry analyte profile IVD, calibrator
Device Class
Class C 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 C
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