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Huac

by Tianjin HUAC Healthcare Technology Co., Ltd. 2 variants

Ref 06955009300443Model HDR500-OP

Active European Union

CE IVDD

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06955009300443 Basic UDI-DI 06955009300443UDI-DIDate22 Nov 2023RegisteredStatusActive

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  • Withdrawn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/IVDD Active

Specification

EUDAMED

Device Name
Digital Pregnancy & Ovulation Test
Model / Reference
HDR500-OP, 06955009300443
Primary DI / UDI-DI
06955009300443
Basic UDI-DI
B-06955009300443
EMDN Code
W0102160399 Fertility/pregnancy rt & poc - other
Device Class
Class IVD devices for self-testing
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000038800
Authorised representative
Brückenkopf GmbH DE-AR-000038468

Other devices from Tianjin HUAC Healthcare Technology Co., Ltd.

  • Huac

    IVD for self-testing

Properties

  • Self Testing
  • Near-Patient Testing
  • Surgical Instrument

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Professional Testing: No
  • Companion Diagnostics: No