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myOrbit Soft

by mylife Diabetes Care AG EUDAMED

Active European Union

Ref MYOYP3161

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number764028148000224 Basic UDI-DIDate31 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
myOrbit Infusion Set
Model / Reference
MYOYP3161
Primary DI / UDI-DI
07640281482183
Basic UDI-DI
764028148000224
EMDN Code
A03040101 Kits for continuous subcutaneous insulin infusion
Device Class
Class IIb
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CH-MF-000044659
Authorised representative
mylife Distribution GmbH DE-AR-000005922

Other devices from mylife Diabetes Care AG

See all devices from mylife Diabetes Care AG →

Properties

  • Sterile
  • Administering Medicine

Other properties (11)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No