Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015142935

FEI Number

3015142935

Entity Name

DONGGUAN SIMZO ELECTRONIC TECHNOLOGY CO., LTD.

City/State/Country

Dongguan Guangdong, CN

Establishment Address

No.6, Zhangzhou Road, Daojiao Town,, Dongguan Guangdong 523187, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Dongguan SIMZO Electronic Technology Co., Ltd. (Owner Number: 10059316)

Owner / Operator Contact Address

No.6, Zhangzhou Road, Daojiao Town, Dongguan City, Guangdong Province, 523187, P.R. China, Dongguan, CN-GD 523187, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Infrared Forehead Thermometer HW-F1, HW-F2, HW-F3, HW-F4, HW-F5, HW-F6, HW-F7, HW-F8, HW-B05; Infrared Thermometer HW-E01, HW-E02, HW-E03, HW-E04; clinical electronic thermometer TH-801, TH-802, TH-803, TH-804 Portable (Ultrasonic) Nebulizer; Portable Mesh Nebulizer; Portable Nebulizer; Mesh Nebulizer NBM-3B, NBM-4B, NBM-5B, NBM-6B, NBM-7B, NBM-8B, NBM-9B, NBM-10N NBM-1, NBM-2, NBM-3, NBM-4, NBM-5, NBM-6, NBM-7, NBM-8, NBM-9, NBM-10, NBM-11 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 Nebulizer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
SDV	Clinical Electronic Thermometer	General Hospital	Class 2	880.2910	2025-08-16
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2023-12-07
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Anesthesiology	Class 1	868.5640	2024-01-12

Official Correspondent

Jack Jin

US Agent Details

Anna Sun Email: usa@medpath.pro Phone: (626) 2005096

Related Public Records

Same Entity

Dongguan SIMZO Electronic Technology Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K163485	Adherium (Nz), Ltd.	SmartTouch	2017-08-30
K781467	Travenol Laboratories, S.A.	U-FLOAT VALVE 2D9023	1978-09-07

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015142935. Last updated year: 2026. Please use registration number 3015142935 when referencing this establishment in official correspondence.