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i-Check Cartridge

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

Ref BE3Model BE3,ELE-I, ELE-Ⅱ, ELE-Ⅲ, BG3, BG7, BG8, BG9-Ⅰ, BG9-Ⅱ, BG10-Ⅰ, BG10-Ⅱ

EMDN W0201040185

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-16972337852199 Basic UDI-DIDate24 Dec 2024RegisteredStatusActive

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

Device Name
i-Check Cartridge
Model / Reference
BE3, ELE-I, ELE-Ⅱ, ELE-Ⅲ, BG3, BG7, BG8, BG9-Ⅰ, BG9-Ⅱ, BG10-Ⅰ, BG10-Ⅱ
Primary DI / UDI-DI
16972337852199
Basic UDI-DI
B-16972337852199
EMDN Code
W0201040185 Blood gas analysers - consumables
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 & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 9be0174b-98a4-4743-9050-ad4195358820 61 fields · synced 22 Oct 2026