Guangzhou Daxin Health Technology (Dongguan) Co., Ltd.
Registered establishment in Dongguan, Guangdong, China. 7 device types.
Guangzhou Daxin Health Technology (Dongguan) Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Oximeter, Dispenser, Solid Medication and 5 other device types. Its earliest product listing with the FDA dates from 2021.
Registration
| Registered name | Guangzhou Daxin Health Technology (Dongguan) Co., Ltd |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3019470217 |
| FEI number | 3019470217 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Location
| City | Dongguan |
|---|---|
| Province | Guangdong |
| Address | Room 601, Building 3, No. 9, Jinshagang Road 1, Dalang Town |
| Postal code | 523792 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Analyzer, Body Composition, Exempt | Class 2 | eF-806W,eF-807W,eF-916W,eF-917W,eF-918W,eF-917WP,WW390XF,Koogeek-S1,WW390F,SF-371,S-3, EF-803B4,EF-804B4,EF-805B4,EF-806B4,EF-807B4,EF-914B4,EF-915B4,EF-917B4,eF-914B4P,eF-712B4,eF-671B4,eF-918B4P,eF-918B4SP,eF-804B4SP, EF-651B4,EF-654B4,EF-655B4,EF-670B4,EF-706B4,EF-802B4,EF-916B4,eF-706B4S,eF-918B4PL,eF-917B4P,eF-804B4P,eF-919B4,eF-919B4S,T9140, Body Composition Scale, eF-804B4P-Tuya,eF-916B4S,eF-919B4P,eF-919B4SP,eF-706W,eF-804W,GN-WA005-199,eF-654W,eF-655W,eF-670W,eF-802W,eF-803W,eF-805W, LAH5CB4-BT and 1 more | 2021 | 36 |
| Clinical Electronic Thermometer | Class 2 | T30,TE-82,TE-79,TE-102,EQ-HW-TH-500-BK,MT1,TE-66,B-FT102, Clinical Electronic Thermometer | 2025 | 49 |
| Continuous Measurement Thermometer | Class 2 | Thermometer, MT1, TE-66, T30, TE-82, TE-79, TE-102, Infrared Thermometer | 2022 | 115 |
| Dispenser, Solid Medication | Class 1 | EQ-HW-PB-200-CR/YH001, EQ-HW-PB-700-AC/YH008, Pill Planner; Pill Dispensor, BD-HW-PB-500-AC/YH006, DXYH-002, DXYH-003 and 18 more | 2025 | 68 |
| Massager, Therapeutic, Electric | Class 1 | EYE Massager, DX-206,DX-207,DX-208,DX-300.DX-301,DX-302 | 2024 | 437 |
| Oximeter | Class 2 | Fingertip Pulse Oximeter | 2022 | 70 |
| System, Measurement, Blood-Pressure, Non-Invasive | Class 2 | Blood Pressure Meter, MS1, ePA-46B,ePA-46B5,ePA-13B4,PA-09,ePA-09B4, Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D) | 2022 | 98 |
Clearances
No clearance names Guangzhou Daxin Health Technology (Dongguan) Co., Ltd. as applicant. 4 are held by other companies 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 |
|---|---|---|---|---|
| K261136 | 2026-07-23 | DXN | Traditional | Guangzhou Daxin Health Technology Co., Ltd. |
| K243082 | 2025-04-25 | FLL | Traditional | Guangzhou Daxin Health Technology Co., Ltd. |
| K161938 | 2017-05-08 | DQA | Traditional | Xuzhou Yongkang Electronic Science Technology Co., Ltd. |
| K140681 | 2014-08-21 | FLL | Traditional | Shenzhen Belter Health Measurement and Analysis TE |
From the Company
Published by the company on its own website, not by the FDA.
| Factory area | 8,000 square meters |
|---|---|
| Main products | Infrared thermometers, Blood pressure monitors, Body fat scales, Weighing scales |
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.