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myOrbit Soft

by mylife Diabetes Care AG Switzerland EUDAMED

Ref MYOYP2461

EMDN A03040101

Regulatory status

as of 24 Oct 2026

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

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
myOrbit Infusion Set
Model / Reference
MYOYP2461
Primary DI / UDI-DI
07640281482060
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 & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 9a10cb96-6409-40e0-b4e3-7dfc887fd4f8 61 fields · synced 22 Oct 2026