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mylife Aveo Glucose Control Solutions

by i-SENS, Inc. 3 variants

Ref 700026276Model GCD02

Active European Union

CE IVDR

Valid until

29 Jan 2029

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 Number8806712BGMCS007VM Basic UDI-DI 08806712005782UDI-DIDate14 May 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • V76 090700 0062 Active Supplemented

    Technical documentation EU IVDR

    Certifier
    TÜV SÜD Product Service GmbH 0123
    Issued
    3 Mar 2026
    Expires
    29 Jan 2029
    Reason
    Change approved

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
GCD02, 700026276
Primary DI / UDI-DI
08806712005782
Basic UDI-DI
8806712BGMCS007VM
EMDN Code
W010106010801 Blood test strips controls
Device Class
Class C
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
KR-MF-000009173
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from i-SENS, Inc.

See all devices from i-SENS, Inc. →

Properties

  • Reagent
  • Self Testing
  • Professional Testing

Other properties (8)

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