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i-Check Cartridge

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

Ref ELE-Ⅱ

EMDN W0101060610

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06972337858026 Basic UDI-DIDate20 Apr 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

Device Name
i-Check Cartridge
Model / Reference
ELE-Ⅱ
Primary DI / UDI-DI
06972337858026
Basic UDI-DI
B-06972337858026
EMDN Code
W0101060610 Blood gas incl. electrolytes / metabolites - multi use 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 & raw data

Show properties, registry sources and raw records
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED ae0de386-9289-4f3f-82e0-ef35887ff237 61 fields · synced 22 Oct 2026