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Blood Glucose Meter

by Changsha Contec Yixin Biotechnology Co., Ltd. 21 variants

Ref CMS10DModel CMS10A

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 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  • Withdrawn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 Meter
Model / Reference
CMS10A, CMS10D
Primary DI / UDI-DI
06976064467452
Basic UDI-DI
697606446CMS10K5
Direct Marketing DI
06976064467452
EMDN Code
W0201060102 Blood glucose meters
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

  • 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