Skip to content

Urea/BUN – (Modified Urease - Berthlot Method)

by Egyptian Company For Biotechnology-Spectrum Diagnostics Egypt EUDAMED

Ref 318 004 EMDN W01010204

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-62230041038896 Basic UDI-DIDate15 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  • Withdrawn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 23 Oct 2026

Model / Reference
318 004
Primary DI / UDI-DI
62230041038896
Basic UDI-DI
B-62230041038896
EMDN Code
W01010204 Urea/blood urea nitrogen
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
EG-MF-000032599
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Egyptian Company For Biotechnology-Spectrum Diagnostics

See all devices from Egyptian Company For Biotechnology-Spectrum Diagnostics →

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 a6094b7a-87d4-42e3-8bbf-926381527ab1 61 fields · synced 23 Oct 2026