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US
Last updated May 23, 2026
What Fudakang Industries Co., Ltd. makes
Fudakang Industries Co., Ltd. manufactures infrared thermometers, including models FT-F11-BT, FT-F21-BT, FT-31-BT, and FT-F41-BT, as well as digital thermometers such as BT-A11CN, BT-A21CN, and BT-A41CN. These devices are designed for non-invasive temperature measurement, commonly used in medical and consumer settings for rapid readings.
The company’s products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. These devices are registered in the United States, where Fudakang Industries Co., Ltd. is based.
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 Fudakang Industries Co., Ltd. manufacture?
Fudakang Industries Co., Ltd. specializes in non-invasive temperature measurement devices. Specifically, they produce infrared thermometers (such as the FT-F11-BT, FT-F21-BT, FT-31-BT, and FT-F41-BT) and digital thermometers (including models like BT-A11CN, BT-A21CN, and BT-A41CN). These devices are designed for quick, contactless or minimal-contact temperature readings, commonly used in both medical and consumer applications.
Where is Fudakang Industries Co., Ltd. based, and where are their devices registered?
Fudakang Industries Co., Ltd. is headquartered in the United States. Their devices are registered in the U.S. regulatory system, where they are listed via the FDA’s 510(k) pathway, indicating compliance with applicable medical device regulations.
How are Fudakang Industries Co., Ltd.’s devices classified under FDA regulations?
Fudakang Industries Co., Ltd.’s devices are classified as Class II medical devices under FDA regulations. This classification applies to products that generally pose moderate risk and require special controls to ensure safety and effectiveness, such as temperature measurement devices used in medical settings.
Which regulatory registries or databases list Fudakang Industries Co., Ltd.’s devices?
Fudakang Industries Co., Ltd.’s devices are listed in the FDA’s 510(k) registry. This registry tracks medical devices that have been determined to be substantially equivalent to legally marketed devices through the 510(k) clearance process, ensuring they meet regulatory requirements for marketing in the U.S.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
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- PRRC Contact
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- EUDAMED SRN
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- DUNS Number
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Catalogue (44)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Fdk | BT-A11CN | FDA UDI | Class II | Active |
| Fdk | FT-F34 | FDA UDI | Class II | Active |
| Fdk | FT-F41A | FDA UDI | Class II | Active |
| Fdk | FT-B11W-V | FDA UDI | Class II | Active |
| Fdk | FT-C23Y | FDA UDI | Class II | Active |
| Fdk | FT-B12W-V | FDA UDI | Class II | Active |
| Fdk | FT-C03-V | FDA UDI | Class II | Active |
| Aupo | FT-F21 | FDA UDI | Class II | Active |
| Fdk | FT-F21 | FDA UDI | Class II | Active |
| Fdk | BT-A13 | FDA UDI | Class II | Active |
| Fdk | FT-B14W-V | FDA UDI | Class II | Active |
| Fdk | BT-A11CN | FDA UDI | Class II | Active |
| Fdk | FT-C15B | FDA UDI | Class II | Active |
| Fdk | BT-A41CN | FDA UDI | Class II | Active |
| Fdk | FT-C15Y-V | FDA UDI | Class II | Active |
| Fdk | FT-C21Y-V | FDA UDI | Class II | Active |
| Fdk | FT-F32 | FDA UDI | Class II | Active |
| Fdk | FT-C22Y | FDA UDI | Class II | Active |
| Fdk | FT-E688 Plus | FDA UDI | Class II | Active |
| Fdk | FT-C11B-V | FDA UDI | Class II | Active |
| Aupo | FT-B13W | FDA UDI | Class II | Active |
| Fdk | BT-A41CN-BT | FDA UDI | Class II | Active |
| Fdk | FT-C02-V (XL) | FDA UDI | Class II | Active |
| Fdk | FT-C02-V (L) | FDA UDI | Class II | Active |
| Fdk | FT-B04-V | FDA UDI | Class II | Active |
| Fdk | FT-F41 | FDA UDI | Class II | Active |
| Fdk | FT-B22Y-V | FDA UDI | Class II | Active |
| Fdk | FT-C23Y-V | FDA UDI | Class II | Active |
| Fdk | FT-E688 | FDA UDI | Class II | Active |
| Fdk | FT-C12B-V | FDA UDI | Class II | Active |
| Fdk | BT-A21CN | FDA UDI | Class II | Active |
| Fdk | FT-B13W-V | FDA UDI | Class II | Active |
| Fdk | FT-F11 | FDA UDI | Class II | Active |
| Prex | BT-A31-BT | FDA UDI | Class II | Active |
| Fdk | BT-A31 | FDA UDI | Class II | Active |
| Fdk | FT-F31 | FDA UDI | Class II | Active |
| Fdk | FT-F33 | FDA UDI | Class II | Active |
| Fdk | FT-C15Y | FDA UDI | Class II | Active |
| Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT) | K160308 | FDA 510(k) | Class II | Active |
| Arm Blood Pressure Monitor, Wrist Blood Pressure Monitor | K150430 | FDA 510(k) | Class II | Active |
| Infrared Thermometer (FT-F11-BT, FT-F21-BT, FT-31-BT, FT-F41-BT) | K152640 | FDA 510(k) | Class II | Active |
| Digital Thermometer | K172121 | FDA 510(k) | Class II | Active |
| Infrared Ear Therometer | K111703 | FDA 510(k) | Class II | Active |
| Digital Thermometer, Models Bt-A11cn, Bt-A21cn, Bt-A41cn | K101387 | 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.
- Fudakang Industrial Co Ltd Dongguan Guangdong · CN FEI 3008167616