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Sign in to claim this brandGuangdong Transtek Medical Electronics Co., Ltd
China·CN-MF-000010684
Last updated May 30, 2026
What Guangdong Transtek Medical Electronics Co., Ltd makes
The company manufactures portable automatic-inflation electronic sphygmomanometers designed for arm or wrist use, as well as in-the-ear air-conduction hearing aids. These devices include branded models such as Ciśnieniomierz DOMOWY, Cardidom, and Alfacheck SMART VOICE, which are intended for home blood pressure monitoring and hearing assistance. Additional products like Misuratore di pressione, ZORA, Lifehood, Metene, and Meraw serve similar consumer-focused applications. The portfolio also includes branded devices like Health Wealth Safe, Brilliant Care, and ASTART, which cater to blood pressure measurement and related health monitoring needs.
The company’s devices are authorised under various regulatory frameworks, including Class I, Class II, and Class IIa classifications. Products are listed in the EU’s eudamed registry, the FDA’s 510(k) clearance system, and the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from Guangdong, China.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Guangdong Transtek Medical Electronics Co., Ltd primarily manufacture?
Guangdong Transtek Medical Electronics Co., Ltd specialises in two main categories: portable automatic-inflation electronic sphygmomanometers for arm or wrist use, which measure blood pressure, and in-the-ear air-conduction hearing aids. These devices are designed for consumer use, often marketed under brands like Ciśnieniomierz DOMOWY, Cardidom, and Alfacheck SMART VOICE for blood pressure monitoring, as well as Misuratore di pressione and ZORA for similar purposes. The company’s focus is on home health monitoring solutions.
Where is Guangdong Transtek Medical Electronics Co., Ltd based, and how does this affect its regulatory approach?
The company is based in Guangdong, China. This location influences its regulatory strategy, as it must comply with both domestic Chinese regulations and international frameworks like those in the EU and the US. For example, its devices are listed in the EU’s eudamed registry and the FDA’s 510(k) and UDI systems, reflecting its global market presence and adherence to varied regulatory requirements for authorised devices.
Which regulatory registries list devices manufactured by Guangdong Transtek Medical Electronics Co., Ltd?
Devices from Guangdong Transtek Medical Electronics Co., Ltd are listed in three key regulatory registries: the EU’s eudamed system, the FDA’s 510(k) clearance database for premarket notifications, and the FDA’s Unique Device Identifier (UDI) database. These listings indicate where individual devices have undergone the necessary authorisation processes to meet regulatory standards in those regions.
How are the devices manufactured by Guangdong Transtek Medical Electronics Co., Ltd classified under regulatory frameworks?
The company’s devices are classified under three regulatory categories: Class I, Class II, and Class IIa. Class I devices typically pose the lowest risk and may require general controls, while Class II and Class IIa devices involve higher risk and require additional performance standards or special controls. For example, automatic-inflation sphygmomanometers and hearing aids may fall into these classes depending on their intended use and potential risks, ensuring appropriate regulatory oversight.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- China
- Address
- Zone A, No. 105 Dongli Road, Torch Development District 528437 Zhongshan, Guangdong PEOPLE'S REPUBLIC OF CHINA, zhongshan , China
- Website
- transtekcorp.com
- —
- —
- [email protected]
- Phone
- 999-999-9999
- PRRC Contact
- Jialong Fan
- EUDAMED SRN
- CN-MF-000010684
- FDA FEI Number
- —
- DUNS Number
- 679794078
Catalogue (82)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ciśnieniomierz DOMOWY | BBZ32-AB01 | EUDAMED | Class IIa | Active |
| Cardidom | LS802-GP | EUDAMED | Class IIa | Active |
| Alfacheck SMART VOICE | BBZ32-AA01 | EUDAMED | Class IIa | Active |
| Misuratore di pressione | TMB-1491-S | EUDAMED | Class IIa | Active |
| Zora | TMB-2275-K | EUDAMED | Class IIa | Active |
| Lifehood | TMB-2085-008 | FDA UDI | Class II | Active |
| Lifehood | TMB-1491-S-072 | FDA UDI | Class II | Active |
| Metene | TMB-2083 | FDA UDI | Class II | Active |
| Meraw | TMB-2084 | FDA UDI | Class II | Active |
| Health Wealth Safe | TMB-2092-Ga | FDA UDI | Class II | Active |
| Brilliant Care | TMB-2092-Ga | FDA UDI | Class II | Active |
| Astart | TMB-1581-ZY | FDA UDI | Class II | Active |
| Brilliant Care | LS802-GS | FDA UDI | Class II | Active |
| Meraw | TMB-2084 | FDA UDI | Class II | Active |
| Transtek | TMB-2084-A | FDA UDI | Class II | Active |
| TeleRPM | TMB-2092-G | FDA UDI | Class II | Active |
| Ezfast | TMB-2080-K | FDA UDI | Class II | Active |
| Caretouch | PSW01 | FDA UDI | Class II | Active |
| Health Connect | TMB-2092-G | FDA UDI | Class II | Active |
| Patient Doctor Connect &TeleRPM | TMB-2092-Ga | FDA UDI | Class II | Active |
| Astart | TMB-1581-ZY | FDA UDI | Class II | Active |
| Transtek | LS802-GS | FDA UDI | Class II | Active |
| Astart | TMB-1581-ZY | FDA UDI | Class II | Active |
| Transtek | LS802-GP | FDA UDI | Class II | Active |
| TeleMate Health | TMB-2092-G | FDA UDI | Class II | Active |
| Meraw | TMB-2084 | FDA UDI | Class II | Active |
| Cadence | TMB-2092-G | FDA UDI | Class II | Active |
| DrKumo | TMB-2092-Ga | FDA UDI | Class II | Active |
| Riva Health | LS802-GP | FDA UDI | Class II | Active |
| Meraw | TMB-2088-C | FDA UDI | Class II | Active |
| WebCareHealth | LS802-GP | FDA UDI | Class II | Active |
| Meraw | TMB-2085-K | FDA UDI | Class II | Active |
| Lifehood | TMB-2080-K | FDA UDI | Class II | Active |
| Meraw | LS808-S | FDA UDI | Class II | Active |
| TeleRPM | TMB-2084-A | FDA UDI | Class II | Active |
| Insignia | NS-BPMW1 | FDA UDI | Class II | Active |
| TeleRPM | TMB-2092-Ga | FDA UDI | Class II | Active |
| TrueBlue MD | LS802-GP | FDA UDI | Class II | Active |
| Caretouch | PSW01-B | FDA UDI | Class II | Active |
| ethizo | LS802-GP | FDA UDI | Class II | Active |
| Veris Health | TMB-2084-A | FDA UDI | Class II | Active |
| Lifehood | TMB-2084-KT-003 | FDA UDI | Class II | Active |
| Lifesense | TMB-1598-BN | FDA UDI | Class II | Active |
| Linner | Nova | FDA UDI | Class II | Active |
| TeleMate Health | TMB-2092-Ga | FDA UDI | Class II | Active |
| lifehood | TMB-1775 | FDA UDI | Class II | Active |
| Meraw | TMB-2084 | FDA UDI | Class II | Active |
| TeleRPM | LS802-GP | FDA UDI | Class II | Active |
| Linner | Nova | FDA UDI | Class II | Active |
| TeleRPM | TMB-2092-Ga | FDA UDI | Class II | Active |
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