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Controls

by Edan Instruments, Inc. China EUDAMED

Ref Blood Gas and Electrolyte Control Level 1 EMDN W0101050204

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06944413847514 Basic UDI-DIDate4 Jan 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  • Withdrawn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 22 Oct 2026

Model / Reference
Blood Gas and Electrolyte Control Level 1
Primary DI / UDI-DI
06944413847514, 06944413809079, 06944413815551
Basic UDI-DI
B-06944413847514, B-06944413809079, B-06944413815551
EMDN Code
W0101050204 Electrolyte controls
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000009957
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Edan Instruments, Inc.

See all devices from Edan Instruments, Inc. →

Properties & raw data

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

Sources (3)

  • EUDAMED 645914a3-e637-46b0-ac4c-ee94798010e8 61 fields · synced 22 Oct 2026
  • EUDAMED 06944413809079|B-06944413809079 61 fields · synced 10 Jul 2026
  • EUDAMED 06944413815551|B-06944413815551 61 fields · synced 5 Oct 2026