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HCG Pregnancy Rapid Tests for self-testing

by Innovita (Tangshan) Biological Technology Co., Ltd. 9 variants

Ref YF103M009Model Strip:YF101S001,YF101S002,YF101S003; Cassette: YF102C004, YF102C005, YF102C006; Midstream:YF103M007.YF103M008.YF103M009

Active European Union

CE IVDR

Valid until

11 Mar 2030

CE IVDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier TÜV Rheinland LGA Products GmbH

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 Number697064009YF101EV Basic UDI-DIDate18 Sep 2025RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
HCG Pregnancy Rapid Tests for self-testing
Model / Reference
Strip:YF101S001, YF101S002, YF101S003, Cassette: YF102C004, YF102C005, YF102C006, Midstream:YF103M007.YF103M008.YF103M009, YF103M009
Primary DI / UDI-DI
06970640090331
Basic UDI-DI
697064009YF101EV
Direct Marketing DI
06970640090331
EMDN Code
W0102160302 Hcg - rt & poc
Device Class
Class B
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000018424
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Innovita (Tangshan) Biological Technology Co., Ltd.

See all devices from Innovita (Tangshan) Biological Technology Co., Ltd. →

Properties

  • Self Testing

Other properties (10)

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