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Tandem Mobi System

by Tandem Diabetes Care, Inc. EUDAMED

Active European Union

Ref 1016914

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberMDR 824766 Date2 Sep 2026IssuedStatusActive expires 14 May 2030

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 824766 Supplemented

    Technical documentation EU MDR

    Notified body
    Notified body 2797
    Issued
    2 Sep 2026
    Expires
    14 May 2030
    Reason
    Change approved

Specification

EUDAMED

Model / Reference
1016914
Primary DI / UDI-DI
00389152691411
Basic UDI-DI
00389152TF0018738ZJ
EMDN Code
Z120402160103 Portable insulin microinfusors connectable to continuous glucose monitoring systems
Device Class
Class III
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000031791
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Tandem Diabetes Care, Inc.

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Properties

  • Administering Medicine

Other properties (12)

  • Sterile: No
  • 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