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UDI Compass

Keto-Diastix

Certificate valid

Snapshot 2026-10-31 · Link to EUDAMED

UDI-DI 15016003288309Basic UDI-DI 15016003KDSTIXUBKZ

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Class C · IVDR · Ascensia Diabetes Care Holdings AG

Identification

Model
KDSTIX-U-XXXXYY
Issuing agency
GS1
Device status
active
Sterile
No

Certificates

IVDR 785591

EU technical documentation assessment · valid

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

Valid from 2025-07-08 · Expiry 2030-07-07

Scope not stated in certificate data.

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

Manufacturer

Ascensia Diabetes Care Holdings AG

SRN CH-MF-000034124

CH · Basel

manufacturer

Authorised representative: Ascensia Diabetes Care Italy Srl (IT-AR-000025584)

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/keto-diastix-8309 · UDI page: /udi/15016003288309

All devices from Ascensia Diabetes Care Holdings AG