GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO.,LTD

FDA Device Registration & Listing · Zhongshan Guangdong, CN · Registration 3011420269

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3011420269
FEI Number
3011420269
Entity Name
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO.,LTD
City/State/Country
Zhongshan Guangdong, CN
Establishment Address
Zone A, No.105, Dongli Road, Torch Development District, Zhongshan Guangdong 528437, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Guangdong Transtek Medical Electronics Co.,Ltd (Owner Number: 10048437)
Owner / Operator Contact Address
Zone A, No.105 ,Dongli Road,, Torch Development District, Zhongshan, CN-GD 528437, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K123669
PMA Number
N/A

All Registered Proprietary Names

Blood Pressure Monitor,Model : TMB-2296-BT,TMB-2296-B Trakr Healthcare Smart Blood Pressure Monitor, Model: TMB-2296-B Easy@Home Blood Pressure Monitor,Model : EBP-96B Blood Pressure Monitor: TMB-2084-T,TMB-2084-A PSW01 Metene Blood Pressure Monitor, Model:TMB-1117-SN; HYLOGY Blood Pressure Monitor,Model: LS810-S iProven Blood Pressure Monitor, model: BPM-337 Blood Pressure Monitor,Model: TMB-1598-S Renpho Blood Pressure Monitor , Model: R-J004;Renpho Blood Pressure Monitor , Model: RP-BPM001 Lifehood digital blood pressure monitor, Model:TMB-1491-S Meraw Blood Pressure Monitor Irregular Heartbeat Monitoring, Model Number LS808-S Renpho Blood Pressure Monitor , Model: TMB-1872-T Blood Pressure Monitor , Model: TMB-1491-BS GRANZIA Automatic Blood Pressure Monitor,Model: TMB-995-S , TMB-1585-S Easy@Home Blood Pressure Monitor, Model : EBP-095 GLAMOR Blood Pressure Monitor, Model: TMB-1490-CS , TMB-1873 Etekcity Smart Blood Pressure Monitor, Model :TMB-1583-BS 1 BY ONE Bluetooth Blood Pressure Monitor Model:703NA-0005; TMB-1585-BT Blood Pressure Monitor,model: ABP-2088-T Blood Pressure Monitor,Model : TMB-2080-K,TMB-2088, TMB-2083; Blood Pressure Monitor,Model :51-1490 Easy@Home Blood Pressure Monitor,Model: EBP-08B VILIBRUN Blood Pressure Monitor, Model :BM1585 Renpho Smart Blood Pressure Monitor , Model:TMB-1872-B Dario Smart Blood Pressure Monitor Gen 2, Model :1217-05 Renpho Smart Blood Pressure Monitor , Model:RP-BPM001S EZFAST Blood Pressure Monitor,Model : TMB-2080-K Meraw Blood Pressure Monitor Irregular Heartbeat Monitoring, Dual Users, Model Number: TMB-2088-C BPM-35 Blood Pressure Monitor,Model:BBZ32-AA01,BBZ32-CA01,BBZ32-AB01,BBZ32-BA01,BBZ32-BB01,BBZ32-DB01,BBZ32-DA01 Pulse Body Fat Analyzer,Model:GBF-2008-B TeleRPM Body Fat Analyzer,Model:GBF-2008-B TeleRPM Blood Pressure Monitor ,Model :TMB-2092-Ga B200 Hearing Aids; Common Name: Linner Nova-lite; Model: Nova Wrist Blood Pressure Monitor,Model:TMB-1581-ZY Blood Pressure Monitor,Model:BWZ51,BWZ52 Blood Pressure Monitor,Model:TMB-2285-BT,TMB-2285-BK Wrist Blood Pressure Monitor, Model:TMB-988-S Blood Pressure Monitor, Model:TMB-1117-SN Withings BPM Vision, Model: WPM07, REF: WPM07-08 Withings BPM Pro 2, Model: WPM07, REF: WPM07-07 Withings BPM Pro 2,Model:WPM07 Blood pressure monitor TMB-2287-B Hilo Cuff Aktiia Init I1 LifeHood Blood Pressure Monitor ,Model :TMB-2085 Easy@Home Wrist Blood Pressure Monitor, Model: EBP-085 ; Easy@Home Wrist Blood Pressure Monitor,Model: TMB-2085 Meraw Wrist Blood Pressure Monitor Irregular Heartbeat Monitoring, Model Number: TMB-2085-K

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DQA Oximeter Cardiovascular Class 2 870.2700 2025-06-11
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2024-07-09
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2022-09-09
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2015-01-26
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2022-09-04
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2015-01-14
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2015-01-26
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2023-11-14
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2024-06-24
PUH Analyzer, Body Composition, Exempt Cardiovascular Class 2 870.2770 2025-09-09
DQA Oximeter Cardiovascular Class 2 870.2700 2023-10-07
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2023-11-14
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2021-03-09
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2015-12-08
QRK Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2025-12-22
FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2025-12-22
QRL Multiple Use Blood Lancet For Single Patient Use Only General, Plastic Surgery Class 2 878.4850 2025-12-22
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2016-10-27
QUG Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter Ear, Nose, Throat Class 2 874.3305 2023-01-04
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2024-03-22
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2024-05-24
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2026-05-27
PGJ Oximeter, Wellness Cardiovascular Class 2 870.2700 2025-06-20
QRL Multiple Use Blood Lancet For Single Patient Use Only General, Plastic Surgery Class 2 878.4850 2023-11-14
QRK Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2023-11-14
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2015-01-26

Official Correspondent

Jerry Fan

US Agent Details

Clare Ho Business: SHARE INFO INC. Email: cfrhealthcare@foxmail.com Phone: (929) 14102

Related Public Records

Same Entity

Guangdong Transtek Medical Electronics 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
K903523 Hewlett-Packard Co. HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE 1990-10-23
K973147 Nellcor Puritan Bennett, Inc. NPB-295 PULSE OXIMETER 1997-11-14
K231243 Guangdong Genial Technology Co., Ltd. Finger Clip Pulse Oximeter 2023-10-31
K971628 Somanetics Corp. SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS) 1997-10-10
K153184 Shenzhen Caremed Medical Technology Co., Ltd. Caremed Reusable & Disposable SPO2 Sensors 2017-01-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0020-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
Capnostream20 (US) M, Part Number CS08653
Z-0029-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
Capnostream20 (US) M W/PRINTER, Part Number CS08659

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011420269. Last updated year: 2026. Please use registration number 3011420269 when referencing this establishment in official correspondence.
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