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Aria H. pylori Ab Combo Rapid Test

by CTK Biotech Inc. 5 variants

Ref R0191C-50T-ARModel R0191C

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

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 Number081011446R0191CEC Basic UDI-DI 00810114461563UDI-DIDate4 Sep 2026RegisteredStatusActive

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

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
H. pylori Ab Combo Rapid Test
Model / Reference
R0191C, R0191C-50T-AR
Primary DI / UDI-DI
00810114461563
Basic UDI-DI
081011446R0191CEC
EMDN Code
W0105010402 H. pylori antibody assays
Device Class
Class B
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000024900
Authorised representative
MDSS GmbH DE-AR-000005430

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Properties

  • Animal Tissues
  • Microbial Substances
  • Professional Testing

Other properties (8)

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