Unknown / Not in EUDAMED

Snapshot 2026-10-27 · Link to EUDAMED

newgen medicals Portable (Ultrasonic) Nebulizer

UDI-DI 06959989131738Basic UDI-DI 69599891XZNEB0001KC

Class IIa · MDR · Dongguan SIMZO Electronic Technology Co., Ltd.

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Identification

Model: —
EMDN: Z12040210
Issuing agency: GS1
Device status: active
Sterile: No
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

CN25/00001354

EU quality management system · unknown

Notified body: SGS Belgium NV (1639)

Valid from 2026-05-26 · Expiry 2030-03-06

Scope not stated in certificate data.

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

Manufacturer

Dongguan SIMZO Electronic Technology Co., Ltd.

SRN CN-MF-000015642

CN · Dongguan City, Guangdong Province

manufacturer

Authorised representative: MedPath GmbH (DE-AR-000000087)

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Canonical device page: /device/newgen-medicals-portable-ultrasonic-nebulizer-1738 · UDI page: /udi/06959989131738

All devices from Dongguan SIMZO Electronic Technology Co., Ltd.

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