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Portable (Ultrasonic) Nebulizer

EUDAMEDFDA 510(k)

Class IIa (EU MDR)

Ref NBM-9Model 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-9B510(k) K230379

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-9 EUDAMED

Identifiers

Primary DI / UDI-DI
06959989130144 EUDAMED
Basic UDI-DI
69599891XZNEB0001KC EUDAMED
Direct Marketing DI
06959989130144 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 — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Dongguan SIMZO Electronic Technology Co., Ltd.
EUDAMED SRN
CN-MF-000015642
Authorised Representative
MedPath GmbH DE-AR-000000087

Sources (2)

  • EUDAMED 27982941-1410-4088-a3ce-e894626ac904 85 fields · synced Jun 18, 2026
  • FDA 510(k) K230379 1 fields · synced May 18, 2026