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t:slim X2 Insulin Pump with Control-IQ technology

by Tandem Diabetes Care, Inc. EUDAMED

Active European Union

Ref 1005617

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberMDR 761832 Date1 Jun 2026IssuedStatusActive expires 31 Aug 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  • Withdrawn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 761832 Supplemented

    Technical documentation EU MDR

    Notified body
    Notified body 2797
    Issued
    1 Jun 2026
    Expires
    31 Aug 2030
    Reason
    Change approved

Specification

EUDAMED

Device Name
t:slim X2 Insulin Pump
Model / Reference
1005617
Primary DI / UDI-DI
00850006613335
Basic UDI-DI
0389152TF00098599U
EMDN Code
Z120402160103 Portable insulin microinfusors connectable to continuous glucose monitoring systems
Device Class
Class III
Market of Registration
Italy

Manufacturer details

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

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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