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Shenzhen Dongdixin Technology Co., Ltd.

✓ Record-verifiedregistrations found in 11 marketsEU SRN CN-MF-000009429Unified social credit code 91440300715275040J

This company holds 12 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Canada, Singapore, Australia, Hong Kong, Israel, Russia — 10 overseas markets.

Registrations by market

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

CNChinaNMPA

12China registrations

Class I 1Class II 11

as of 2026-09-04

EUEuropean UnionEUDAMED

24UDI-DI device records

Class I 5Class IIa 19

USUnited StatesFDA openFDA

18listed device types

Class I 1Class II 17Class III 0

plus 19 registration records and 26 510(k)

UKUnited KingdomMHRA PARD

9registered device records

Class I 1Class IIa 8

BRBrazilANVISA

3registered devices

Class II 3

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

4active device licences

Class II 4

34 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

6device registrations

CLASS B 6

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

10active ARTG entries

Class I 1IIa 6IIb 3

HKHong KongMDACS

7valid listings

Class II 7

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

5active registrations

Class 2a 5

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 Union24 raw hits, 0 excluded, 24 confirmed

United States19 registration records, 26 510(k), 0 PMA

China12 certificates (Class III 0 / II 11 / I 1), as of 2026-09-04

United Kingdom9 confirmed, 0 excluded

Brazil3 confirmed, 0 excluded

Canada4 confirmed, 0 excluded

Manufacturer names merged into this page: Shenzhen Dongdixin Technology Co., Ltd. · SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD. · SHENZHEN DONGDIXIN TECHNOLOGY CO. LTD.

Regulatory identity

EU manufacturer SRN: CN-MF-000009429
EU authorised representative: Shanghai International Holding Corp. GmbH(Europe)
UK responsible person: Etheria Medical Ltd
Unified social credit code: 91440300715275040J
Exhibition record: Rehab & Elderly Care Expo (Spring 2026, Shanghai) · Rehab & Elderly Care Expo (Spring 2024, Shanghai)

Business registration

Registration status: Active
Incorporated: 2000-03-01
Registered capital: CNY 2,000,000
Paid-in capital: CNY 2,000,000
Legal form: Limited liability company (foreign-invested, not wholly owned)
Industry classification: Computer, communications and other electronic equipment
Last approval date: 2022-09-26
Recognitions: Micro and small enterpriseNational High-Tech EnterpriseInnovative SME

Business registration data from Tianyancha, as of 2026-09-02. 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

12005

12008

12009

42010

12011

12012

22013

32014

22015

12016

32017

22018

12021

12022

12024

12026

FDA listed device types

showing 8 of 18

Stimulator, Neuromuscular, External Functional 1Stimulator, Nerve, Transcutaneous, Over-The-Counter 1Stimulator, Muscle, Powered 1Stimulator, Nerve, Electrical, Transcutaneous, For Migraine 1Stimulator, Electrical, Non-Implantable, For Incontinence 1Cable, Electrode 1Lamp, Infrared, Therapeutic Heating 1Device, Biofeedback 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	粤械注准20242091669	冲击波治疗仪	Class II
CN	粤械注准20232090555	冲击波治疗仪	Class II
CN	粤械注准20232090314	超声电刺激治疗仪	Class II
CN	粤械注准20172070181	红外线体温计	Class II
EU	06926408711369	—	Class IIa
EU	06926408721252	TecarPhysio	Class IIa
EU	06926408741649	Magnetic belt	Class I
EU	06926408740314	Self-adhesive electrodes	Class I
UK	47790	Shock wave therapy device	Class IIa
UK	63711	Infrared Thermometer	Class IIa
UK	47103	Bite Gone	Class IIa
US	K260412	TENS 7000 Rechargeable 4 Channel (TENS 7000H)	2026-06-26
US	K240358	ShockPhysio Mobile (model SW3200 Basic)	2024-06-05
US	K213043	Levator Elite (Model LE9011)	2022-02-25
BR	81778819066	Dispositivo de Terapia por Ondas de Choque	Class II
BR	81778819067	Ultrassom e Estimulador Elétrico Neuromuscular	Class II
BR	81778819077	Dispositivo de Terapia TECAR	Class II
CA	97739	EAR THERMOMETER	Class II
CA	82713	STIMTEC2	Class II
CA	82714	STIMTEC4	Class II