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Pregnancy Test

by Tianjin New Bay Bioresearch Co., Ltd.

Ref 10161, 10155, 10157Model 2 Midstreams/Kit, 1 Midstream/Kit

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06934142910092 Basic UDI-DI Date16 Apr 2025RegisteredStatusActive

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  • Withdrawn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
Pregnancy Urine Tests for Self-testing
Model / Reference
10161, 2 Midstreams/Kit, 10155, 1 Midstream/Kit, 10157
Primary DI / UDI-DI
06934142910092, 06934142910023, 06934142910016, 06934142910030
Basic UDI-DI
B-06934142910092, B-06934142910023, B-06934142910016, B-06934142910030
EMDN Code
W0102160302 Hcg - rt & poc
Device Class
Class IVD devices for self-testing
EU market of registration
Northern Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000040564
Authorised representative
MedEnvoy Global BV NL-AR-000024028

Other devices from Tianjin New Bay Bioresearch Co., Ltd.

See all devices from Tianjin New Bay Bioresearch Co., Ltd. →

Properties

  • Animal Tissues
  • Reagent
  • Self Testing
  • Near-Patient Testing

Other properties (6)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No