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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-12 · Link to EUDAMED

Tandem AI Medical Guide

UDI-DI 07350179820026Basic UDI-DI 735017982TANDEMGUIDE7M

Class IIa · MDR · Tandem Health AB

Identification
Model
—
EMDN
V92
Issuing agency
GS1
Device status
active
Sterile
No
Implantable
No
Measuring function
No
Reusable surgical
No
Certificates

SCAR-9.2.1.7

EU quality management system · unknown

Notified body: Scarlet NB B.V. (3022)

Valid from 2026-09-16 · Expiry 2031-02-15

Scope not stated in certificate data.

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

Manufacturer

Tandem Health AB

SRN SE-MF-000049463

SE · Stockholm

manufacturer

Related UDI-DIs

No other UDI-DIs share this Basic UDI-DI in this snapshot.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/tandem-ai-medical-guide-0026 · UDI page: /udi/07350179820026

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