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Controls

by Edan Instruments, Inc. China EUDAMED

Ref CO-Oximeter Control Level 2

EMDN W0101050204

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06944413815650 Basic UDI-DIDate4 Jan 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
CO-Oximeter Control Level 2
Primary DI / UDI-DI
06944413815650, 06944413815643, 06944413847569
Basic UDI-DI
B-06944413815650, B-06944413815643, B-06944413847569
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 6e1ff324-9966-4f1c-8b1d-4c5ee5529a0a 61 fields · synced 22 Oct 2026
  • EUDAMED 06944413815643|B-06944413815643 61 fields · synced 16 Jul 2026
  • EUDAMED 06944413847569|B-06944413847569 61 fields · synced 25 Jul 2026