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Blood Glucose Meter

by Contec Medical Systems Co., Ltd. EUDAMED

Active European Union

Ref BGM10BModel BGM10A，BGM10A-BV，BGM10A-L，BGM10B，BGM10B-BV，BGM10B-L，BGM10C，BGM10C-BV，BGM10C-L，BGM10D，BGM10D-BV，BGM10D-L，BGM10E，BGM10E-BV，BGM10E-L，BGM10F，BGM10F-BV，BGM10F-L，BGM10G，BGM10G-BV，BGM10G-L

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberV76 050972 0062 Date27 Aug 2026IssuedStatusActive expires 26 Aug 2031

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Specification

EUDAMED

Model / Reference
BGM10A，BGM10A-BV，BGM10A-L，BGM10B，BGM10B-BV，BGM10B-L，BGM10C，BGM10C-BV，BGM10C-L，BGM10D，BGM10D-BV，BGM10D-L，BGM10E，BGM10E-BV，BGM10E-L，BGM10F，BGM10F-BV，BGM10F-L，BGM10G，BGM10G-BV，BGM10G-L, BGM10B
Primary DI / UDI-DI
06945040113430
Basic UDI-DI
69450401BGM10FH
Direct Marketing DI
06945040113430
EMDN Code
W0201060102 Blood glucose meters
Device Class
Class C
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000007715
Authorised representative
Prolinx GmbH DE-AR-000005129

Other devices from Contec Medical Systems Co., Ltd.

See all devices from Contec Medical Systems Co., Ltd. →

Properties

  • Self Testing
  • Surgical Instrument

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • New Device: No