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Atellica CH Cholesterol_2 (Chol_2)

by Siemens Healthcare Diagnostics Inc. EUDAMED

Active European Union

Ref 11645761Model IVDR_67_TTN_DUB-C_B_REAG_CHOL_c

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0405686901683W6 Basic UDI-DIDate17 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

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.

Specification

EUDAMED

Device Name
IVDR_67_TTN_DUB-C_B_REAG_CHOL_c
Model / Reference
IVDR_67_TTN_DUB-C_B_REAG_CHOL_c, 11645761
Primary DI / UDI-DI
00630414654157
Basic UDI-DI
0405686901683W6
Unit of Use DI
00630414322131
EMDN Code
W01010205 Cholesterol
Device Class
Class B
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000016560
Authorised representative
Siemens Healthcare Diagnostics Manufacturing Limited IE-AR-000006763

Other devices from Siemens Healthcare Diagnostics

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Properties

  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No