Data / Medical devices / China / Guangdong Transtek Medical Electronics Co.,ltd

Guangdong Transtek Medical Electronics Co.,ltd: FDA-registered device maker in Zhongshan Guangdong, China, 25 510(k) clearances

Guangdong Transtek Medical Electronics Co.,ltd is registered with the FDA (registration 3011420269) in Zhongshan Guangdong, China. It lists 11 device types. The FDA files 25 510(k) clearances under its listings, the newest dated January 30, 2025. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

FDA registration number

3011420269

Address

Zone A, No.105, Dongli Road Torch Development District, Zhongshan Guangdong, China, 528437

Owner or operator

Guangdong Transtek Medical Electronics Co.,Ltd (10048437)

Roles

Contract manufacturer, Exporter to the US, Manufacturer

First device listed

January 14, 2015

Registered through

2027

Brand names listed

1 BY ONE Bluetooth Blood Pressure Monitor Model:703NA-0005; TMB-1585-BT, 32nd Street Media Blood Pressure Monitor, Model: TMB-2284-B, Aktiia Init I1, BPM-35, Blood Pressure Monitor , Model: TMB-1491-BS, Blood Pressure Monitor ,Model :TMB-2084-KT, Blood Pressure Monitor, Model : BBY31-BT1,BBY31-1, Blood Pressure Monitor, Model : TMB-1776-ZY and more

Devices it lists

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Compare with other makers

• All makers of System, Measurement, Blood-Pressure, Non-Invasive
• All makers of System, Test, Blood Glucose, Over The Counter
• All makers of Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
• All makers of Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
• All makers of Multiple Use Blood Lancet For Single Patient Use Only
• All makers of Scale, Patient

Updated January 30, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.