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Urine microalbumin/Creatinine ratio (ACR) Panel

by Yantai JIEZI Biotechnology Co., Ltd. EUDAMED

Active European Union

Ref 03050002Model 10 tests/kit

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06978189070418 Basic UDI-DIDate24 Aug 2026RegisteredStatusActive

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  • Withdrawn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

Model / Reference
10 tests/kit, 03050002
Primary DI / UDI-DI
06978189070418
Basic UDI-DI
B-06978189070418
EMDN Code
W0101060205 Urine multi-constituent test strips (automated)
Device Class
Class IVD General
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000044146
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Yantai JIEZI Biotechnology Co., Ltd.

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Properties

Show properties
  • Reagent
  • Near-Patient Testing
  • Professional Testing
  • Surgical Instrument
Other properties (6)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No