Skip to content

Atellica IM HIV Ag/Ab Combo (CHIV)

by Siemens Healthcare Diagnostics Inc.

Ref 10995527Model IVDR_67_TTN_DUB-C_D_KIT_HIV Ag/Ab Combo

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0405686901884WJ Basic UDI-DI 00630414598543UDI-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  • Withdrawn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_KIT_HIV Ag/Ab Combo
Model / Reference
IVDR_67_TTN_DUB-C_D_KIT_HIV Ag/Ab Combo, 10995527
Primary DI / UDI-DI
00630414598543
Basic UDI-DI
0405686901884WJ
EMDN Code
W0105030404 HIV multiple ag/ab combi test
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

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

Other properties (6)

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