Shenzhen Hetaida Technology Limited Company
Registered establishment in Shenzhen, Guangdong, China. 4 device types.
Shenzhen Hetaida Technology Limited Company is an exporter holding a current FDA establishment registration. The registration covers Pad, Menstrual, Unscented, Pack, Hot Or Cold, Disposable and 2 other device types. Its earliest product listing with the FDA dates from 2023.
Registration
| Registered name | SHENZHEN HETAIDA TECHNOLOGY LIMITED COMPANY |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3026032283 |
| FEI number | 3026032283 |
| Establishment type | Exporter |
Chinese Registration
| Chinese legal name | 深圳市和泰达科技有限公司 |
|---|---|
| Source | Qichacha company register |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | Room 2209, Tower A, CR Land Qianhai Building, No.5035 Menghai Ave., Nanshan District |
| Postal code | 518052 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Attachment, Commode, Wheelchair | Class 1 | Upside Down Peri Bottle | 2024 | 70 |
| Continuous Measurement Thermometer | Class 2 | Non-Contact Infrared Body Thermometer, Infrared Body Thermometer, Model: HTD8220US, Infrared Ear Thermometer, Model: HTD8208C, Infrared Body Thermometer | 2023 | 115 |
| Pack, Hot Or Cold, Disposable | Class 1 | Instant Ice Maxi Pads, Postpartum lce Pack Pads | 2024 | 176 |
| Pad, Menstrual, Unscented | Class 1 | Postpartum Catch-All Pads, Postpartum Pads | 2024 | 132 |
Clearances
No clearance names Shenzhen Hetaida Technology Limited Company as applicant. 4 are held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K203332 | 2021-02-25 | FLL | Special | Hetaida Technology Co., Ltd. |
| K200159 | 2021-01-05 | FLL | Traditional | Hetaida Technology Co., Ltd. |
| K180387 | 2019-01-10 | FLL | Traditional | Hetaida Technology Co., Ltd. |
| K171888 | 2018-07-23 | FLL | Traditional | Hetaida Technology Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2009 |
|---|---|
| Main products | Infrared thermometers, electronic blood pressure monitors, electric nasal aspirators, compressor nebulizers, hearing aids |
| Certifications | FDA, CE, ROHS, ISO13485, NMPA, SMETA, CPA |
| Export markets | More than 100 countries; 2 million units annual sales |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.