Data / Medical devices / China / Hetaida Technology Co., Ltd.
Hetaida Technology Co., Ltd.: FDA-registered device maker in Dongguan Guangdong, China, 9 510(k) clearances
Hetaida Technology Co., Ltd. is registered with the FDA (registration 3017493034) in Dongguan Guangdong, China. It lists 8 device types. The FDA files 9 510(k) clearances under its listings, the newest dated February 7, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017493034
- Address
- Room 801,802,803,804,901, 2# Building Scientific Research Center, Songhu Intelligent Valley, No.6 Minfu Road, Liaobu Town, Dongguan City, Guangdong Province, Dongguan Guangdong, China, 523423
- Owner or operator
- HeTaiDa Technology Co., Ltd (10058025)
- Roles
- Contract manufacturer, Manufacturer, Specification developer
- First device listed
- June 27, 2018
- Registered through
- 2026
- Brand names listed
- BNT100, BNT100CA, BNT100CAV1, BNT100US, Behind-the-Ear Hearing Aid, model: HTD6102US, Electronic Blood Pressure Monitor, Model: D6606US, D6607US, Electronic blood pressure monitor, model: HTD6601US; HTD6602US; HTD6603US; HTD6605US; D6606US; D6607US, H2603US and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Attachment, Commode, Wheelchair | INB | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Clinical Electronic Thermometer | SDV | 2 | Manufacturer | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Contract manufacturer, Manufacturer, Specification developer | accessdata.fda.gov |
| Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter | QUG | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Hearing Aid, Air-Conduction, Over The Counter | QUF | 1 | Manufacturer | accessdata.fda.gov |
| Pad, Menstrual, Unscented | HHD | 1 | Contract manufacturer | accessdata.fda.gov |
| Pump, Portable, Aspiration (Manual Or Powered) | BTA | 2 | Manufacturer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 7, 2025 | K243661 | Electronic Blood Pressure Monitor | DXN | Substantially Equivalent | Hetaida Technology Co., Ltd. | accessdata.fda.gov |
| July 1, 2024 | K241202 | Electric nasal aspirator (HTD2601US) | BTA | Substantially Equivalent | Hetaida Technology Co., Ltd. | accessdata.fda.gov |
| December 5, 2023 | K223170 | Electronic Blood Pressure Monitor, model: HTD6602US | DXN | Substantially Equivalent | Hetaida Technology Co., Ltd. | accessdata.fda.gov |
| February 25, 2021 | K203332 | Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C | FLL | Substantially Equivalent | Hetaida Technology Co., Ltd. | accessdata.fda.gov |
| January 5, 2021 | K200159 | Non-contact Infrared Body Thermometer, model:HTD8823US | FLL | Substantially Equivalent | Hetaida Technology Co., Ltd. | accessdata.fda.gov |
| December 9, 2020 | K200781 | Infrared Body Thermometer | FLL | Substantially Equivalent | Heitaida Technology Co., Ltd. | accessdata.fda.gov |
| January 10, 2019 | K180387 | Infrared Ear Thermometer | FLL | Substantially Equivalent | Hetaida Technology Co., Ltd. | accessdata.fda.gov |
| July 23, 2018 | K171888 | Non-contact infrared body thermometer | FLL | Substantially Equivalent | Hetaida Technology Co., Ltd. | accessdata.fda.gov |
| May 11, 2018 | K180385 | Infrared Body Thermometer | FLL | Substantially Equivalent | Hetaida Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Pump, Portable, Aspiration (Manual Or Powered)
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Continuous Measurement Thermometer
- All makers of Hearing Aid, Air-Conduction, Over The Counter
- All makers of Pad, Menstrual, Unscented
- All makers of Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter
Updated February 7, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.