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Sign in to claim this brandHangzhou Hua'An Medical & Health Instruments Co.,
US
Last updated May 24, 2026
Part of Hangzhou Hua'an Medical & Health Instruments Co., Ltd.
What Hangzhou Hua'An Medical & Health Instruments Co., makes
The company manufactures electronic and infrared thermometers designed for clinical use, including intermittent electronic devices and non-contact models for measuring skin and ear temperatures. Their portfolio also includes a handheld device for measuring body fat percentage and a digital thermometer with a disposable probe. These products are intended for patient monitoring in healthcare settings.
The devices fall under FDA Class II regulation and are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. The company operates with a presence in the United States, adhering to applicable regulatory requirements for medical thermometers and related diagnostic tools.
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 Hangzhou Hua'An Medical & Health Instruments Co. manufacture?
Hangzhou Hua'An Medical & Health Instruments Co. specializes in electronic and infrared thermometers for clinical use. Their portfolio includes intermittent electronic patient thermometers, as well as non-contact infrared thermometers designed for measuring skin and ear temperatures. Additionally, they produce a handheld device for estimating body fat percentage and a digital thermometer with a disposable probe, all intended for patient monitoring in healthcare settings.
Where is Hangzhou Hua'An Medical & Health Instruments Co. based?
The company has a presence in the United States, where it operates and adheres to applicable regulatory requirements for its medical devices. While the company is listed under a Chinese name, its regulatory and commercial activities are conducted within the US market.
Which regulatory registries list Hangzhou Hua'An Medical & Health Instruments Co.'s devices?
The company’s devices are listed in the FDA’s 510(k) premarket notification database and the Unique Device Identifier (UDI) system. These registries are used to track and classify medical devices that require regulatory clearance or approval in the United States.
How are Hangzhou Hua'An Medical & Health Instruments Co.'s devices classified by the FDA?
All of Hangzhou Hua'An Medical & Health Instruments Co.'s listed devices fall under FDA Class II classification. This classification is assigned based on the level of risk associated with the device—Class II devices generally pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (32)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Jasun | FT-100D | FDA UDI | Class II | Active |
| femometer | DT-01D | FDA UDI | Class II | Active |
| Iif | DT-01D | FDA UDI | Class II | Active |
| Jasun | DT-K111J | FDA UDI | Class II | Active |
| Essef | T208 | FDA UDI | Class II | Active |
| Essef | T208 | FDA UDI | Class II | Active |
| Essef | T516 | FDA UDI | Class II | Active |
| Essef | T104 | FDA UDI | Class II | Active |
| Rexall | DT-Y111D | FDA UDI | Class II | Active |
| Essef | T516 | FDA UDI | Class II | Active |
| Iif | DT-101B | FDA UDI | Class II | Active |
| Essef | T104 | FDA UDI | Class II | Active |
| Iif | DT-111B | FDA UDI | Class II | Active |
| Rexall | FT-100B | FDA UDI | Class II | Active |
| Rexall | DT-101B | FDA UDI | Class II | Active |
| Rexall | DT-01D | FDA UDI | Class II | Active |
| Marathon Health | DT-111D | FDA UDI | Class II | Active |
| Jasun | DT-K111I | FDA UDI | Class II | Active |
| Essef | T104 | FDA UDI | Class II | Active |
| Rexall | ET-100B | FDA UDI | Class II | Active |
| Essef | T104 | FDA UDI | Class II | Active |
| Essef | T516 | FDA UDI | Class II | Active |
| Infra-red ear thermometer model: ET-100A, ET-100B, ET-100D, ET-100E, ET-100G, ET-100I, ET-100J | K172870 | FDA 510(k) | Class II | Active |
| Upperarm Digital Blood Pressure Monitor, Model: Mb-300 Series | K092514 | FDA 510(k) | Class II | Active |
| Digital thermometer(with disposable thermometer cover) | K172861 | FDA 510(k) | Class II | Active |
| Wrist Digital Blood Pressure Monitor (digital Sphygmomanometer), Mw-300 Series | K041693 | FDA 510(k) | Class II | Active |
| Infra-red forehead thermometer | K160999 | FDA 510(k) | Class II | Active |
| Infrared Ear Thermometer, Et-100 Series | K041692 | FDA 510(k) | Class II | Active |
| Digital Flexible Thermometer, Basic Digital Thermometer, Ditital Pacifier Thermometer | K041694 | FDA 510(k) | Class II | Active |
| Digital Thermometer (with Disposable Thermometer Cover) | K122912 | FDA 510(k) | Class II | Active |
| Digital Thermometer (with Disposable Thermometer Cover), Dt Series | K092447 | FDA 510(k) | Class II | Active |
| Jasun, Models Dt-01f And Dt-11f | K030361 | FDA 510(k) | Class II | Active |
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