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Blood Glucose Test Strip

by Contec Medical Systems Co., Ltd.

Ref BG-01-30

Active European Union

CE IVDR

Valid until

26 Aug 2031

CE IVDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier TÜV SÜD Product Service GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

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

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
BG-01-30
Primary DI / UDI-DI
06945040113645, 06945040113652, 06945040113669, 06945040113638
Basic UDI-DI
69450401BG013042
Direct Marketing DI
06945040113645
06945040113652
06945040113669
06945040113638
EMDN Code
W0101060101 Glucose test strips
Device Class
Class C
EU 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

  • Reagent
  • Self Testing

Other properties (9)

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