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H.Pylori Antibody Rapid Test

by Hangzhou Tongzhou Biotechnology Co., Ltd. 4 variants

Ref I021-N4002-40

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number6975156250000DZF Basic UDI-DI 06975156250910UDI-DIDate25 Mar 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  • Withdrawn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

Model / Reference
I021-N4002-40
Primary DI / UDI-DI
06975156250910
Basic UDI-DI
6975156250000DZF
Direct Marketing DI
06975156250910
EMDN Code
W0105090102 H. pylori - rt & poc
Device Class
Class B
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000038774
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Hangzhou Tongzhou Biotechnology Co., Ltd.

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Properties

  • Animal Tissues
  • Professional Testing

Other properties (9)

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