Unknown / Not in EUDAMED

Snapshot 2026-10-27 · Link to EUDAMED

t:slim X2 Insulin Pump with Control-IQ technology

UDI-DI 00850006613328Basic UDI-DI 0389152TF00098599U

Class III · MDR · Tandem Diabetes Care, Inc.

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Identification

Model: —
EMDN: Z120402160103
Issuing agency: GS1
Device status: active
Sterile: No
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

MDR 761832

EU technical documentation assessment · unknown

Notified body: BSI Group The Netherlands B.V. (2797)

Valid from 2026-06-01 · Expiry 2030-08-31

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

Manufacturer

Tandem Diabetes Care, Inc.

SRN US-MF-000031791

US · San Diego, California

manufacturer

Authorised representative: MDSS GmbH (DE-AR-000005430)

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t:slim X2 Insulin Pump with Control-IQ technology 00850006613335
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t:slim X2 Insulin Pump with Control-IQ+ technology 00389152694719
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All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/t-slim-x2-insulin-pump-with-control-iq-technology-3328 · UDI page: /udi/00850006613328

All devices from Tandem Diabetes Care, Inc.

Scan an inventory CSV