Medwell Technology Limited
Registered establishment in Dongguan, Guangdong, China. 10 device types, 1 clearance.
Medwell Technology Limited is a contract manufacturer holding a current FDA establishment registration. The registration covers Syringe, Piston, Catheter, Irrigation and 8 other device types. Its earliest product listing with the FDA dates from 2012.
10device types registered with the FDA
1510(k) clearance
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3009107690 |
| FEI number | 3009107690 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 維爾醫療器械科技有限公司 |
|---|---|
| Source | Hong Kong company register lookup |
Location
| City | Dongguan |
|---|---|
| Province | Guangdong |
| Address | 2nd Floor, 5th Building No. 136 Gangjian Road |
| Postal code | 523570 |
| 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, Model: K5101US; Peri Bottle, Model: K5102US | 2025 | 70 |
| Bottle, Collection, Vacuum | Class 2 | Electric Nasal Aspirator, Model: HTD2601US, HTD2602US, H2603US, H2605US, H2606US, H2609AU, H2609US | 2025 | 88 |
| Catheter, Irrigation | Class 1 | Saphenous Vein Distention System, irrigation beveled and blunt cannula, sterile and nonsterile | 2015 | 24 |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | Class 1 | Breathing circuit | 2015 | 55 |
| Continuous Measurement Thermometer | Class 2 | Non-contact Infrared Body Thermometer,Model:HTD8808C,HTD8813C,HTD8818A,VNT275US, Infrared Body Thermometer,Model:H8831US, Non-Contact 3-in-1 Thermometer, Non-contact Infrared Body Thermometer,Model:HTD8808C,HTD8813C,HTD8818A, No Touch Forehead Thermometer,Model:BNT100US,VNT200US, Infrared Body Thermometer,Model:HTD8220US | 2025 | 115 |
| Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter | Class 2 | Behind-the-Ear Hearing Aid, model: HTD6102US | 2025 | 52 |
| Pack, Hot Or Cold, Disposable | Class 1 | Instant Ice Maxi Pads, Postpartum Ice Pack Pads, Model: K5201US, K5202US | 2025 | 176 |
| Pad, Menstrual, Unscented | Class 1 | Postpartum Catch-All Pads, Model: K5501US; Postpartum Pads, Model: K5502US | 2025 | 132 |
| Syringe, Piston | Class 2 | Medline Industries, LP – Northfield, Polycarbonate Syringe | 2012 | 60 |
| System, Measurement, Blood-Pressure, Non-Invasive | Class 2 | Electronic Blood Pressure Monitor,D6606US,D6607US | 2025 | 98 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K212764 | 2022-11-04 | FMF | 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.