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Blood Gas/Ion/Metabolite Control

by B&E Bio-Technology Co., Ltd. EUDAMED

Active European Union

Ref BQC Level 1: 2.0ml×5、Level 2: 2.0ml×5、Level 3: 2.0ml×5

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06972337852987 Basic UDI-DIDate17 Jul 2025RegisteredStatusActive

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  • Withdrawn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

Device Name
Blood Gas/Ion/Metabolite Control
Model / Reference
BQC Level 1: 2.0ml×5、Level 2: 2.0ml×5、Level 3: 2.0ml×5
Primary DI / UDI-DI
06972337852987
Basic UDI-DI
B-06972337852987
EMDN Code
W0101060607 Blood gas controls - electrodes or cassette
Device Class
Class IVD General
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000023256
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from B&E Bio-Technology Co., Ltd.

See all devices from B&E Bio-Technology Co., Ltd. →

Properties

  • Reagent
  • Professional Testing

Other properties (8)

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