Dongguan E-Test Technology Co., Ltd.
Manufacturer and brand owner in Dongguan, Guangdong, China. 3 device types, 2 products catalogued, 5 clearances.
Dongguan E-Test Technology Co., Ltd. is a repacker / relabeller holding a current FDA establishment registration. The registration covers Continuous Measurement Thermometer, Strip, Temperature, Forehead, Liquid Crystal and 1 other device type. 2 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2020.
3device types registered with the FDA
2products catalogued under its own name
5510(k) clearances
Registration
| Registered name | DONGGUAN E-TEST TECHNOLOGY CO.,LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3017896172 |
| FEI number | 3017896172 |
| DUNS | 554511666 |
| Establishment type | Repacker / relabeller, Private-label distributor, Complaint-file establishment, Manufacturer |
Chinese Registration
| Chinese legal name | 东莞一测科技有限公司 |
|---|---|
| Unified social credit code | 91441900MA53H2PH59 |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Dongguan |
|---|---|
| Province | Guangdong |
| Address | Room 201, 301, Building 1, Changping Section No.1, Dongshen Road, Changping Town |
| Postal code | 523570 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Continuous Measurement Thermometer | Class 2 | Digital Thermometer (Model BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318) | 2020 | 115 |
| Strip, Temperature, Forehead, Liquid Crystal | Class 2 | Forehead thermometer strips, model: MDSTS101 | 2021 | 17 |
| System, Measurement, Blood-Pressure, Non-Invasive | Class 2 | 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 845X, BA-847X, BA-849X, BA-851X, BA-852X, BA 855X, BA-835), Automatic Upper Arm Blood Pressure Monitor (model: BA-815, BA-816), 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-821X, BA-822X, BA-823X, BA-826X, BA-818, BA-819, 1001e, MDS1001UE) and 3 more | 2020 | 98 |
Own-Brand Listings
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K250231 | 2025-09-03 | DXN | Traditional | This company |
| K193621 | 2020-11-23 | FLL | Traditional | This company |
| K193627 | 2020-07-12 | DXN | Traditional | This company |
| K193628 | 2020-07-12 | DXN | Traditional | This company |
| K193624 | 2020-07-10 | DXN | Traditional | This company |
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.