Skip to content
UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-12 · Link to EUDAMED

Tandem Mobi System

UDI-DI 00389152691213Basic UDI-DI 00389152TF0018738ZJ

Class III · MDR · Tandem Diabetes Care, Inc.

Identification
Model
—
Issuing agency
GS1
Device status
active
Sterile
No
Implantable
No
Measuring function
No
Reusable surgical
No
Certificates

MDR 824766

EU technical documentation assessment · unknown

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

Valid from 2026-09-02 · Expiry 2030-05-14

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)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/tandem-mobi-system-1213 · UDI page: /udi/00389152691213

Scan an inventory CSV