Skip to content

YpsoPump Orbitsoft Infusion Set

by Ypsomed AG EUDAMED

Withdrawn No longer placed on the EU market

Ref MYOYP3161

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-07613117010584 Basic UDI-DIDate6 Oct 2026RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Withdrawn

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Model / Reference
MYOYP3161
Primary DI / UDI-DI
07613117010584
Basic UDI-DI
B-07613117010584
EMDN Code
A03040101 Kits for continuous subcutaneous insulin infusion
Device Class
Class IIb

Manufacturer details

EUDAMED SRN
CH-MF-000016749
Authorised representative
Ypsomed Produktion GmbH DE-AR-000055930

Other devices from Ypsomed AG

See all devices from Ypsomed AG →

Properties

  • Sterile

Other properties (10)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No