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Blood Glucose Control Solution

by Changsha Contec Yixin Biotechnology Co., Ltd. 3 variants

Ref BG-01

Active European Union

CE IVDR

Valid until

20 Sep 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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberV76 133576 0002 Date21 Sep 2026IssuedStatusActive expires 20 Sep 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  • Withdrawn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

Device Name
Blood Glucose Control Solution
Model / Reference
BG-01
Primary DI / UDI-DI
06976064467339
Basic UDI-DI
697606446BG01HZ
Direct Marketing DI
06976064467339
EMDN Code
W010106010801 Blood test strips controls
Device Class
Class C
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000043060
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Changsha Contec Yixin Biotechnology Co., Ltd.

See all devices from Changsha Contec Yixin Biotechnology 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