Data / Medical devices / China / Dongguan E-Test Technology Co.,ltd
Dongguan E-Test Technology Co.,ltd: FDA-registered device maker in Dongguan Guangdong, China, 4 510(k) clearances
Dongguan E-Test Technology Co.,ltd is registered with the FDA (registration 3017896172) in Dongguan Guangdong, China. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated September 3, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017896172
- Address
- Room 201, 301, Building 1, Changping Section No.1, Dongshen Road, Changping Town, Dongguan Guangdong, China, 523570
- Owner or operator
- DONGGUAN E-TEST TECHNOLOGY CO.,LTD (10079208)
- Roles
- Complaint file establishment, Foreign private label distributor, Manufacturer, Repackager or relabeler
- First device listed
- November 24, 2020
- Registered through
- 2026
- Brand names listed
- Automatic Upper Arm Blood Pressure Monitor (Model: BA 845X, BA-847X, BA-849X, BA-851X, BA-852X, BA 855X, BA-835), Automatic Upper Arm Blood Pressure Monitor (Model: BA-831X, BA-832X, BA 833X, BA-837X, BA-838X, BA-842X, BA-843X), Automatic Upper Arm Blood Pressure Monitor (Model: BA-836, BA-839, BA-840, BA-856, BPU311), Automatic Upper Arm Blood Pressure Monitor (model :BA-801X, BA-802X, BA-803X, BA-805X, BA-806X, BA-811X, BA-812X, BA-813, Automatic Upper Arm Blood Pressure Monitor (model: BA-815, BA-816), Automatic Upper Arm Blood Pressure Monitor (model: BA-821X, BA-822X, BA-823X, BA-826X, BA-818, BA-819, 1001e, MDS1001UE), Automatic Upper Arm Blood Pressure Monitor (model: BA-832X), Automatic Upper Arm Blood Pressure Monitor (model: MDS1001, MDS1001U, MDS1001UT, MDS1001CS) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | 2 | Manufacturer | accessdata.fda.gov |
| Strip, Temperature, Forehead, Liquid Crystal | KPD | 2 | Complaint file establishment, Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Manufacturer, Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| September 3, 2025 | K250231 | Automatic Upper Arm Blood Pressure Monitor (BA-831X, BA-832X, BA-833X, BA-837X, BA-838X, BA-842X, BA-843X, BA-845X, BA-847X, BA-849X, BA-851X, BA-852X, BA-855X, BA-835, BA-836, BA-839, BA-840, BA-856) | DXN | Substantially Equivalent | Dongguan E-Test Technology Co., Ltd. | accessdata.fda.gov |
| November 23, 2020 | K193621 | Digital Thermometer-(Model BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318) | FLL | Substantially Equivalent | Dongguan E-Test Technology Co., Ltd. | accessdata.fda.gov |
| July 12, 2020 | K193627 | Automatic Upper Arm Blood Pressure Monitor | DXN | Substantially Equivalent | Dongguan E-Test Technology Co., Ltd. | accessdata.fda.gov |
| July 10, 2020 | K193624 | Automatic Upper Arm Blood Pressure Monitor | DXN | Substantially Equivalent | Dongguan E-Test Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Strip, Temperature, Forehead, Liquid Crystal
- All makers of Continuous Measurement Thermometer
Updated September 3, 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.