Huizhou Maxway Technology Co., Ltd.
Registered establishment in Huizhou, Guangdong, China. 2 device types.
Huizhou Maxway Technology Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Nystagmograph, Devices, Breath Trapping, Alcohol. Its earliest product listing with the FDA dates from 2021.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3011119387 |
| FEI number | 3011119387 |
| Establishment type | Contract manufacturer, Manufacturer |
Location
| City | Huizhou |
|---|---|
| Province | Guangdong |
| Address | No.9, Dongsheng South Road, Chenjiang, Zhongkai Hi-Tech District |
| Postal code | 516080 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Devices, Breath Trapping, Alcohol | Class 1 | SK-15-AL, SK-15, BT-T15, BACtrack Skyn, SK-15-XL, SK-15-AS and 4 more | 2026 | 16 |
| Nystagmograph | Class 2 | Insight Infrared Video Goggles | 2021 | 3 |
Clearances
No clearance names Huizhou Maxway Technology Co., Ltd. as applicant. One is held by another company 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 |
|---|---|---|---|---|
| K203082 | 2020-11-12 | GWN | Traditional | Vestibular First |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2004 |
|---|---|
| Main products | PCBA, PCB Assembly, electronic components |
| OEM and ODM | Offered |
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.