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UDI Compass
Certificate valid

Snapshot 2026-10-28 · Link to EUDAMED

Erasense Dx Respira

UDI-DI 08684407910609Basic UDI-DI 86844079106ESD001FC

Class C · IVDR · Eras İnovasyon ve İleri Mühendislik Teknolojileri A.Ş.

Identification
Model
—
Issuing agency
GS1
Device status
active
Sterile
No
Certificates

ITDA/00008/0v001

EU technical documentation assessment · valid

Notified body: QMD Services GmbH (2962)

Valid from 2026-10-09 · Expiry 2031-10-08

Scope not stated in certificate data.

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

Manufacturer

Eras İnovasyon ve İleri Mühendislik Teknolojileri A.Ş.

SRN TR-MF-000037278

TR · Izmir

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/erasense-dx-respira-0609 · UDI page: /udi/08684407910609

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