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Dongguan Simzo Electronic Technology Co.,Ltd.

✓ Record-verifiedregistrations found in 7 marketsEU SRN CN-MF-000015642Unified social credit code 91441900576434450G

This company holds 5 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Australia, Israel — 6 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

5China registrations

Class II 5

as of 2026-09-04

EUEuropean UnionEUDAMED

112UDI-DI device records

Class IIa 112

USUnited StatesFDA openFDA

4listed device types

Class I 1Class II 3Class III 0

plus 5 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

2registered device records

Class IIa 2

BRBrazilANVISA

6registered devices

Class II 6

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IIa 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union112 raw hits, 0 excluded, 112 confirmed

United States5 registration records, 3 510(k), 0 PMA

China5 certificates (Class III 0 / II 5 / I 0), as of 2026-09-04

United Kingdom2 confirmed, 0 excluded

Brazil6 confirmed, 0 excluded

Manufacturer names merged into this page: DONGGUAN SIMZO ELECTRONIC TECHNOLOGY CO., LTD.

Regulatory identity

EU manufacturer SRN: CN-MF-000015642
EU authorised representative: MedPath GmbH
UK responsible person: MedPath Limited
Unified social credit code: 91441900576434450G
Exhibition record: Rehab & Elderly Care Expo (Spring 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Business registration

Registration status: Active
Incorporated: 2011-06-01
Registered capital: CNY 10,000,000
Paid-in capital: CNY 10,000,000
Legal form: Limited liability company (natural-person invested or controlled)
Industry classification: Pharmaceutical manufacturing
Last approval date: 2021-12-20
Recognitions: Micro and small enterpriseTechnology-based SMEInnovative SME

Business registration data from Tianyancha, as of 2026-09-03. Public registry information only; legal representative and contact-person details are not collected. The figure is the number of employees enrolled in social insurance as declared by the company, which may differ from actual headcount.

FDA 510(k) clearances by year

12018 · K173048

12021 · K211583

12023 · K230379

FDA listed device types

Nebulizer, Medicinal, Non-Ventilatory (Atomizer) 1Clinical Electronic Thermometer 1Continuous Measurement Thermometer 1Nebulizer (Direct Patient Interface) 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	粤械注准20182070069	医用电子体温计	Class II
CN	粤械注准20172080209	医用压缩雾化器	Class II
CN	粤械注准20172080207	医用网式雾化器	Class II
CN	粤械注准20162070476	红外体温计	Class II
EU	06959989130915	Portable (Ultrasonic) Nebulizer	Class IIa
EU	06959989130908	Portable (Ultrasonic) Nebulizer	Class IIa
EU	06959989130892	Portable (Ultrasonic) Nebulizer	Class IIa
EU	06959989130885	Portable (Ultrasonic) Nebulizer	Class IIa
UK	17888	Infrared Forehead Thermometer	Class IIa
UK	66295	66295	Class IIa
US	K230379	Portable (Ultrasonic) Nebulizer	2023-11-27
US	K211583	Infrared Thermometer, Model: HW-1	2021-09-03
US	K173048	No-contact Forehead Thermometer	2018-12-06
BR	80275319033	Nebulizador de Rede Vibratória	Class II
BR	81861509001	Inalador portátil Mesh Buba	Class II
BR	10410619020	TERMOMETRO DIGITAL POR INFRAVERMELHO	Class II

Dongguan Simzo Electronic Technology Co.,Ltd.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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