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Helicobacter Pylori Detector System

by Hunan Celis Biotech Co., Limited 3 variants

Ref SUBT-D2

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, self-declared

Class I: no certifier involved

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 Number697756210HPDSQQ Basic UDI-DI 06977562100025UDI-DIDate16 Jun 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
SUBT-D2
Primary DI / UDI-DI
06977562100025
Basic UDI-DI
697756210HPDSQQ
Direct Marketing DI
06977562100025
EMDN Code
W0299 IVD instruments - other
Device Class
Class A
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000042425
Authorised representative
MedPath GmbH DE-AR-000000087

Other devices from Hunan Celis Biotech Co., Limited

Properties

  • Professional Testing
  • Surgical Instrument

Other properties (9)

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