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Urea/BUN – (UV)(4+1)

by Kalians Corporation Egypt EUDAMED

Ref D-641 004 EMDN W01010204

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-62230182705848 Basic UDI-DIDate31 Mar 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  • Withdrawn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 · synced 24 Oct 2026

Model / Reference
D-641 004
Primary DI / UDI-DI
62230182705848
Basic UDI-DI
B-62230182705848
EMDN Code
W01010204 Urea/blood urea nitrogen
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
EG-MF-000050142
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Kalians Corporation

See all devices from Kalians Corporation →

Properties & raw data

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

Sources (1)

  • EUDAMED cb6b3850-221d-489e-af40-13633b0d712a 61 fields · synced 24 Oct 2026