Guangdong MacroLux Medical Technology Co., Ltd.
Registered establishment in Dongguan, Guangdong, China. 9 device types.
Guangdong MacroLux Medical Technology Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Stand, Infusion, Hysteroscope Accessories and 7 other device types. Its earliest product listing with the FDA dates from 2024.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3035710892 |
| FEI number | 3035710892 |
| Establishment type | Contract manufacturer, Repacker / relabeller, Manufacturer |
Chinese Registration
| Chinese legal name | 广东星辰海医疗科技有限公司 |
|---|---|
| Unified social credit code | 91441900MAE1CYAW77 |
| Source | provincial manufacturer licence lists |
Location
| City | Dongguan |
|---|---|
| Province | Guangdong |
| Address | 501, Building 6, No.4, Xinxi Road, Songshan Lake High-Tech Industrial Development Zone |
| Postal code | 523787 |
| Country | China |
Group
Guangdong MacroLux Medical Technology Co., Ltd. is one of 2 plants registered under MacroLux Medical Technology Co., Ltd..
| Plant | City | Device types |
|---|---|---|
| Macrolux Medical Technology Co., Ltd. | Shenzhen | 9 |
What It Makes
Clearances
No clearance names Guangdong MacroLux Medical 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 |
|---|---|---|---|---|
| K260516 | 2026-07-20 | FGB | Traditional | Macrolux Medical Technology Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | single-use electronic endoscopes, ureteroscope, urology devices, gynecology devices, ENT devices |
|---|---|
| Export markets | Global |
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.