Data / Medical devices / China / Shenzhen Hetaida Technology Limited Company
Shenzhen Hetaida Technology Limited Company: FDA-registered device maker in Shenzhen City Guangdong, China, 4 510(k) clearances
Shenzhen Hetaida Technology Limited Company is registered with the FDA (registration 3026032283) in Shenzhen City Guangdong, China. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated February 25, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3026032283
- Address
- Room 2209, Tower A, CR Land Qianhai Building, No.5035 Menghai Ave., Nanshan District, Shenzhen City Guangdong, China, 518052
- Owner or operator
- Shenzhen Hetaida Technology Limited Company (10087194)
- Roles
- Exporter to the US
- First device listed
- January 24, 2023
- Registered through
- 2026
- Brand names listed
- Infrared Body Thermometer, Infrared Body Thermometer, Model: HTD8220US, Infrared Ear Thermometer, Model: HTD8208C, Instant Ice Maxi Pads, Postpartum lce Pack Pads, Non-Contact Infrared Body Thermometer, Postpartum Catch-All Pads, Postpartum Pads, Upside Down Peri Bottle
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Attachment, Commode, Wheelchair | INB | 1 | Exporter to the US | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Exporter to the US | accessdata.fda.gov |
| Pack, Hot Or Cold, Disposable | IMD | 1 | Exporter to the US | accessdata.fda.gov |
| Pad, Menstrual, Unscented | HHD | 1 | Exporter to the US | 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 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 |
| 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 |
Compare with other makers
- All makers of Continuous Measurement Thermometer
- All makers of Attachment, Commode, Wheelchair
- All makers of Pad, Menstrual, Unscented
- All makers of Pack, Hot Or Cold, Disposable
Updated February 25, 2021. 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.