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Portable (Ultrasonic) Nebulizer

EUDAMED

Class IIa (EU MDR)

Ref NBM-10NModel NBM-1, NBM-2, NBM-3, NBM-4, NBM-5, NBM-6, NBM-7, NBM-8, NBM-9, NBM-10, NBM-11, NBM-3B, NBM-4B, NBM-5B, NBM-6B, NBM-7B, NBM-8B, NBM-9B

by Dongguan SIMZO Electronic Technology Co., Ltd.

Identity

Trade Name
Portable (Ultrasonic) Nebulizer EUDAMED
Device Name
Portable (Ultrasonic) Nebulizer EUDAMED
Model / Reference
NBM-1, NBM-2, NBM-3, NBM-4, NBM-5, NBM-6, NBM-7, NBM-8, NBM-9, NBM-10, NBM-11, NBM-3B, NBM-4B, NBM-5B, NBM-6B, NBM-7B, NBM-8B, NBM-9B EUDAMED
NBM-10N EUDAMED

Identifiers

Primary DI / UDI-DI
06959989132063 EUDAMED
Basic UDI-DI
69599891XZNEB0001KC EUDAMED
Direct Marketing DI
06959989132063 EUDAMED
EMDN Code
Z12040210 ULTRASONIC NEBULISERS EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

Yes

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Portable (Ultrasonic) Nebulizer by Dongguan SIMZO Electronic Technology Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
CN-MF-000015642
Authorised Representative
MedPath GmbH DE-AR-000000087

Sources (1)

  • EUDAMED 82869464-eca0-4bef-be79-265508639626 61 fields · synced Jun 18, 2026