Skip to content

Semi-quantitative Albumin Urine Test

by Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd. China EUDAMED

Ref SQ50-112 EMDN W0102160101

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06941571850110 Basic UDI-DIDate16 May 2022RegisteredStatusActive

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  • Withdrawn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 24 Oct 2026

Device Name
Semi-quantitative Albumin Urine Test
Model / Reference
SQ50-112
Primary DI / UDI-DI
06941571850110
Basic UDI-DI
B-06941571850110
EMDN Code
W0102160101 Albumin incl. ualbumin rt & poc
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000020607
Authorised representative
CEpartner4U NL-AR-000000111

Other devices from Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.

See all devices from Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 304c4774-679e-4bd8-a7a3-89f184f4b362 61 fields · synced 24 Oct 2026