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mylife Pura Blood Glucose Test Strip

by Bionime Corporation

Ref myl550G15Model GM550

Active European Union

CE IVDR

Valid until

22 Jul 2031

CE IVDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier TÜV Rheinland LGA Products 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 NumberIX 2110160-1 Date23 Jul 2026IssuedStatusActive expires 22 Jul 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  • Withdrawn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 Monitoring System
Model / Reference
GM550, myl550G15
Primary DI / UDI-DI
04710949333607
Basic UDI-DI
471094933BGM000018X
EMDN Code
W0101060101 Glucose test strips
Device Class
Class C
EU market of registration
Sweden

Manufacturer details

EUDAMED SRN
TW-MF-000008450
Authorised representative
Emergo Europe B.V. NL-AR-000000116

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Properties

  • Reagent
  • Self Testing
  • Near-Patient Testing

Other properties (8)

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