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Atellica IM HIV Ag/Ab Combo Quality Control (CHIV QC)

by Siemens Healthcare Diagnostics Inc.

Ref 11200769Model IVDR_67_TTN_DUB-C_D_REAG_ HIV Ag/Ab Combo QC

Active European Union

CE IVDR

Valid until

6 Mar 2029

CE IVDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier TÜV Rheinland LGA Products GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0405686901886WN Basic UDI-DI 00630414229010UDI-DIDate11 Jun 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
IVDR_67_TTN_DUB-C_D_REAG_ HIV Ag/Ab Combo QC
Model / Reference
IVDR_67_TTN_DUB-C_D_REAG_ HIV Ag/Ab Combo QC, 11200769
Primary DI / UDI-DI
00630414229010
Basic UDI-DI
0405686901886WN
EMDN Code
W0105080803 Retrovirus controls - inf.imm.
Device Class
Class D
EU market of registration
Germany

Manufacturer details

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

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Properties

  • Human Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (7)

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