Dongguan Kangweile Electronic Technology Co., Ltd.
Manufacturer and brand owner in Dongguan, Guangdong, China. 1 device type, 1 product catalogued, 2 clearances.
Dongguan Kangweile Electronic Technology Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers System, Measurement, Blood-Pressure, Non-Invasive. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2021.
1device type
1product
2510(k) clearances
Registration
| Registered name | DONGGUAN KANGWEILE ELECTRONIC TECHNOLOGY CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3017424877 |
| FEI number | 3017424877 |
| DUNS | 402740499 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 东莞市康维乐电子科技有限公司 |
|---|---|
| Unified social credit code | 91441900MA4ULHRK8B |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Dongguan |
|---|---|
| Province | Guangdong |
| Address | 4th floor, building D, Yizhong Science Park, 83 Jinsha 2nd Road, Shuikou village, Dalang Town, Dongguan City, |
| Postal code | 523770 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | Class 2 | Electronic Blood Pressure MonitorKWL-W01.KWL-W02.KWL-W03.KWL-W06.KWL-W08.KWL-W09.KWL-W01L, Electronic Blood Pressure MonitorKWL-W01., Electronic Blood Pressure MonitorKWL-B619.KWL-B13.KWL-B15.KWL-B18.KWL-B17, Electronic Blood Pressure MonitorKWL-B118.KWL-B106, Electronic Blood Pressure Monitor (Arm Type) KWL-B112.KWL-B168.KWL-B01L.KWL-B116.KWL-B606.KWL-B808.KWL-B698.KWL-B816, Electronic Blood Pressure Monitor (Arm Type) KWL-818.KWL-819.KWL-B819L.KWL-B21L.KWL-B22L.KWL-819L and 1 more | 2021 | 98 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Electronlc Blood Pressure Monltor | DXN | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K230642 | 2023-08-11 | DXN | Traditional | This company |
| K212171 | 2021-11-01 | 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.
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