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Sign in to claim this brandDONGGUAN E-TEST TECHNOLOGY CO., LTD
US
Last updated May 25, 2026
What DONGGUAN E-TEST TECHNOLOGY CO., LTD makes
The company manufactures portable automatic-inflation electronic sphygmomanometers designed for arm or wrist use, as well as intermittent electronic patient thermometers for measuring body temperature. It also produces somatosensory evoked-potential graphic recorders, which monitor and display nerve signal responses for diagnostic purposes.
These devices are classified as Class II under regulatory frameworks, with records submitted via FDA 510(k) and UDI listings. The company operates within the United States regulatory environment.
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 Dongguan E-Test Technology Co., Ltd manufacture?
Dongguan E-Test Technology Co., Ltd manufactures three primary types of devices: portable automatic-inflation electronic sphygmomanometers for measuring blood pressure on the arm or wrist, intermittent electronic patient thermometers for body temperature monitoring, and somatosensory evoked-potential graphic recorders. These devices are designed for clinical and diagnostic use, covering vital sign measurement and neurological signal assessment.
Where is Dongguan E-Test Technology Co., Ltd based, and under which regulatory framework do its devices operate?
The company is based in the United States, and its devices fall under the FDA’s regulatory framework. Since the devices are classified as Class II, they require premarket notification (510(k)) submissions and Unique Device Identifier (UDI) listings to demonstrate compliance with applicable regulations before commercial distribution.
Which regulatory registries or databases list the company’s devices?
The company’s devices are listed in the FDA’s 510(k) premarket notification database and the FDA’s UDI (Unique Device Identifier) registry. These registries track device submissions and compliance documentation required for Class II medical devices in the U.S. market.
How are the company’s devices classified under regulatory standards, and why does this matter?
The company’s devices are classified as Class II under FDA regulations. This classification indicates a moderate level of risk, requiring special controls beyond general controls to ensure safety and effectiveness. As a result, manufacturers must submit a 510(k) premarket submission to demonstrate that their device is substantially equivalent to a legally marketed predicate device, ensuring compliance before patient use.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 554511666
Catalogue (37)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| agelh | BA-821X | FDA UDI | Class II | Active |
| agelh | BW-611 | FDA UDI | Class II | Active |
| agelh | BW-612 | FDA UDI | Class II | Active |
| agelh | BA-805X | FDA UDI | Class II | Active |
| agelh | BT-308 | FDA UDI | Class II | Active |
| agelh | BT-302 | FDA UDI | Class II | Active |
| agelh | BA-816 | FDA UDI | Class II | Active |
| agelh | BW-613 | FDA UDI | Class II | Active |
| agelh | BA-812X | FDA UDI | Class II | Active |
| agelh | BW-605 | FDA UDI | Class II | Active |
| agelh | BT-318 | FDA UDI | Class II | Active |
| agelh | BA-819 | FDA UDI | Class II | Active |
| agelh | BA-803X | FDA UDI | Class II | Active |
| agelh | BT-303 | FDA UDI | Class II | Active |
| agelh | BA-806X | FDA UDI | Class II | Active |
| agelh | BA-815 | FDA UDI | Class II | Active |
| agelh | BW-602 | FDA UDI | Class II | Active |
| agelh | BT-306 | FDA UDI | Class II | Active |
| agelh | BA-801X | FDA UDI | Class II | Active |
| agelh | BA-811X | FDA UDI | Class II | Active |
| agelh | BA-826X | FDA UDI | Class II | Active |
| agelh | BA-802X | FDA UDI | Class II | Active |
| agelh | BT-305 | FDA UDI | Class II | Active |
| agelh | BA-813X | FDA UDI | Class II | Active |
| agelh | BW-603 | FDA UDI | Class II | Active |
| agelh | BT-311 | FDA UDI | Class II | Active |
| agelh | BA-823X | FDA UDI | Class II | Active |
| agelh | BA-818 | FDA UDI | Class II | Active |
| agelh | BW-601 | FDA UDI | Class II | Active |
| agelh | BA-822X | FDA UDI | Class II | Active |
| agelh | BW-606 | FDA UDI | Class II | Active |
| agelh | BT-301 | FDA UDI | Class II | Active |
| AGE Automatic Wrist Blood Pressure Monitor | K193628 | FDA 510(k) | Class II | Active |
| Automatic Upper Arm Blood Pressure Monitor | K193627 | FDA 510(k) | Class II | Active |
| Automatic Upper Arm Blood Pressure Monitor (BA-831X, BA-832X, BA-833X, BA-837X, BA-838X, BA-842X, BA-843X, BA-845X, BA-847X, BA-849X, BA-851X, BA-852X, BA-855X, BA-835, BA-836, BA-839, BA-840, BA-856) | K250231 | FDA 510(k) | Class II | Active |
| Digital Thermometer-(Model BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318) | K193621 | FDA 510(k) | Class II | Active |
| Automatic Upper Arm Blood Pressure Monitor | K193624 | FDA 510(k) | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Dongguan E-Test Technology Co., Ltd Dongguan Guangdong · CN FEI 3017896172