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QuikPac OneStep LH Test

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

Ref 10420 EMDN W0102160304

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06934142920022 Basic UDI-DIDate16 Apr 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
10420
Primary DI / UDI-DI
06934142920022
Basic UDI-DI
B-06934142920022
EMDN Code
W0102160304 Lh - rt & poc
Device Class
Class IVD devices for self-testing
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 & 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 b4126841-e193-4f75-94e6-6d9b6e002169 61 fields · synced 22 Oct 2026