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H. pylori Antibody Rapid Test

by Hangzhou Alltest Biotech.Co., Ltd. 2 variants

Ref IHP-N402, IHP-N402B-25, IHP-N402J-40, IHP-N402J-25

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number6970277510000EXK Basic UDI-DI Date26 Aug 2022RegisteredStatusActive

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  • Withdrawn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
IHP-N402, IHP-N402B-25, IHP-N402J-40, IHP-N402J-25
Primary DI / UDI-DI
06936983104456, 06936983104449, 06936983109451, 06936983109574, 06936983109567
Basic UDI-DI
6970277510000EXK
EMDN Code
W0105090102 H. pylori - rt & poc
Device Class
Class B
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000010710
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

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Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (8)

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