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Guangdong Transtek Medical Co.,Ltd

China · Zhongshan Guangdong · transtekmed.com

✓ Record-verifiedregistrations found in 13 marketsEU SRN CN-MF-000010684Unified social credit code 914420007408365594

This company holds 20 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 12 overseas markets.

Registrations by market

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

CNChinaNMPA

20China registrations

Class I 1Class II 19

as of 2026-09-04

EUEuropean UnionEUDAMED

72UDI-DI device records

Class I 10Class IIa 62

USUnited StatesFDA openFDA

11listed device types

Class I 2Class II 9Class III 0

plus 30 registration records and 17 510(k)

UKUnited KingdomMHRA PARD

2registered device records

Class IIa 2

BRBrazilANVISA

4registered devices

Class II 4

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

5active device licences

Class II 5

14 including historic records

TWTaiwanTFDA

2valid device licences

Class II 2

SGSingaporeHSA SMDR

3device registrations

CLASS B 3

KRSouth KoreaMFDS GMP

11GMP quality-system certificates

Business type not stated 1Import 9Manufacturing 1

AUAustraliaTGA ARTG

8active ARTG entries

IIa 8

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

16registrations

RURussiaRoszdravnadzor

4active registrations

Class 2a 4

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 Union72 raw hits, 0 excluded, 72 confirmed

United States30 registration records, 17 510(k), 0 PMA, 2 excluded

China20 certificates (Class III 0 / II 19 / I 1), as of 2026-09-04

United Kingdom2 confirmed, 0 excluded

Brazil4 confirmed, 0 excluded

Canada5 confirmed, 0 excluded

Manufacturer names merged into this page: GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO.,LTD · GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD.

Regulatory identity

EU manufacturer SRN: CN-MF-000010684
EU authorised representative: Share info GmbH
UK responsible person: SHARE INFO LTD
Unified social credit code: 914420007408365594
Exhibition record: CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Business registration

Registration status: Active
Incorporated: 2002-07-18
Registered capital: CNY 218,573,688
Paid-in capital: CNY 218,573,688
Legal form: Joint-stock limited company (listed, natural-person invested or controlled)
Industry classification: Computer, communications and other electronic equipment
Last approval date: 2026-08-24
Recognitions: National High-Tech EnterpriseSRDI SMERecognised enterprise technology centreState Key LaboratoryAbove-designated-size industrial enterprise
Listing: Listed on the A-share market

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

32013

12016

12019

12020

12021

12022

42023

42024

12025

FDA listed device types

showing 8 of 11

Analyzer, Body Composition, Exempt 1Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature 1System, Measurement, Blood-Pressure, Non-Invasive 1Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter 1Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature 1Oximeter, Wellness 1Multiple Use Blood Lancet For Single Patient Use Only 1Oximeter 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	粤械注准20262400409	血糖试纸(葡萄糖脱氢酶法)	Class II
CN	粤械注准20262220067	血糖仪	Class II
CN	粤械注准20262070578	上臂式电子血压计	Class II
CN	粤械注准20252070495	腕式电子血压计	Class II
EU	06932825306606	TeleRPM	Class I
EU	06932825306590	TeleRPM	Class I
EU	06932825305135	TRANSTEK	Class IIa
EU	06932825306521	TeleRPM	Class IIa
UK	45617	Blood Pressure Monitor	Class IIa
UK	45617	Blood Pressure Monitor	Class IIa
US	K243060	TeleRPM Gen2 Blood Glucose Monitoring System	2025-01-30
US	K241351	Blood Pressure Monitor (TMB-2092-G)	2024-08-21
US	K240832	Blood Pressure Monitor (BBZ32-AA01)	2024-06-07
BR	81602809003	MONITOR DE PRESSÃO ARTERIAL DE BRAÇO	Class II
BR	81596329044	MONITOR DE PRESSÃO DE PULSO	Class II
BR	81596329020	Monitor de pressão arterial de braço	Class II
CA	96125	WRIST BLOOD PRESSURE MONITOR	Class II
CA	96229	BLOOD PRESSURE MONITOR	Class II
CA	97629	BLOOD PRESSURE CUFF	Class II