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Urinary Microalbumin (mAlb) Assay Kit by Fluorescence Immunochromatographic Method

by Maccura Biotechnology Co., Ltd. 2 variants

Ref EIM4101302, EIM4101303, ECH0101060

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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 26 Oct 2026. What this means

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-EIM4101302E3 Basic UDI-DI Date22 May 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name
Urinary Microalbumin (mAlb) Assay Kit by Fluorescence Immunochromatographic Method
Urinary Microalbumin (mAlb)
Model / Reference
EIM4101302, EIM4101303, ECH0101060
Primary DI / UDI-DI
D-EIM4101302E3, D-EIM4101303E5, D-ECH01010604M
Basic UDI-DI
B-EIM4101302E3, B-EIM4101303E5, B-ECH01010604M
EMDN Code
W0102160101, W0102010309
Device Class
Class IVD General
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000014618
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Maccura Biotechnology Co., Ltd.

See all devices from Maccura Biotechnology Co., Ltd. →

Properties

  • Animal Tissues
  • Microbial Substances YesEUDAMEDNoEUDAMED
  • Reagent
  • Professional Testing

Other properties (6)

  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No