Guangdong Transtek Medical Electronics Co.,Ltd
Zhongshan Guangdong, CN
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO.,LTD appears in FDA device records in Zhongshan Guangdong, CN. FDA records list 17 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 17 510(k) clearances for Guangdong Transtek Medical Electronics Co.,Ltd between 2013 and 2025. The busiest year on record is 2023, with 4. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2013 | 3 |
| 2016 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 4 |
| 2024 | 4 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K243060 | TeleRPM Gen2 Blood Glucose Monitoring System | NBW | Substantially Equivalent | |
| K241351 | Blood Pressure Monitor (TMB-2092-G) | DXN | Substantially Equivalent | |
| K240832 | Blood Pressure Monitor (BBZ32-AA01) | DXN | Substantially Equivalent | |
| K240254 | Blood Pressure Monitor (TMB-2296-BT) | DXN | Substantially Equivalent | |
| K240102 | Blood Pressure Monitor (TMB-2287-B) | DXN | Substantially Equivalent | |
| K233130 | Blood Pressure Monitor | DXN | Substantially Equivalent | |
| K232713 | Blood Pressure Monitor | DXN | Substantially Equivalent | |
| K232621 | Blood pressure monitor | DXN | Substantially Equivalent | |
| K223374 | Blood Pressure Monitor | DXN | Substantially Equivalent | |
| K220676 | Blood Pressure Monitor | DXN | Substantially Equivalent | |
| K202891 | Blood Pressure Monitor | DXN | Substantially Equivalent | |
| K202599 | Transtek Wrist Blood Pressure Monitor | DXN | Substantially Equivalent | |
| K181832 | Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device | DXN | Substantially Equivalent | |
| K161886 | Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure Device | DXN | Substantially Equivalent | |
| K131394 | TRANSTEK GLASS BODY FAT ANALYZER | MNW | Substantially Equivalent | |
| K131395 | TRANSTEK BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | |
| K130311 | TRANSTEK BODY FAT ANALYZER | MNW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3011420269 | 3011420269 | GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO.,LTD | Zone A, No.105, Dongli Road, Zhongshan Guangdong 528437 CN | 2026 | and 1 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- MNWAnalyzer, Body Composition
- PUHAnalyzer, Body Composition, Exempt
- QRLMultiple Use Blood Lancet For Single Patient Use Only
- DQAOximeter
- PGJOximeter, Wellness
- FRWScale, Patient
- FRIScale, Stand-On, Patient
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- QRKSingle Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- NBWSystem, Test, Blood Glucose, Over The Counter
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain