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Suretest Precoce

by Tianjin New Bay Bioresearch Co., Ltd. China EUDAMED

Ref TNG25A-12E

EMDN W0102050206

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-361481999602668 Basic UDI-DIDate11 Apr 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Suretest Precoce Pregnancy Test
Model / Reference
TNG25A-12E
Primary DI / UDI-DI
D-361481999602668
Basic UDI-DI
B-361481999602668
EMDN Code
W0102050206 B- human chorionic gonadotropin (incl. subunit)
Device Class
Class IVD devices for self-testing
Market of Registration
France

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 & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 29cfd43f-8527-4d98-a50c-e71100779fc3 61 fields · synced 22 Oct 2026