Macrolux Medical Technology Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 9 device types, 16 products catalogued, 7 clearances.
Macrolux Medical Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Stand, Infusion, Hysteroscope Accessories and 7 other device types. 16 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2024.
Registration
| Registered name | MACROLUX MEDICAL TECHNOLOGY CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3029929134 |
| FEI number | 3029929134 |
| DUNS | 723490133 |
| Establishment type | Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 深圳市星辰海医疗科技有限公司 |
|---|---|
| Unified social credit code | 91440300MA5GFBJY1M |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | 301, Building 3, NamTai Inno Park In Guang Ming Avenue, Guangming |
| Postal code | 518107 |
| Country | China |
Group
Macrolux Medical Technology Co., Ltd. is one of 2 plants registered under MacroLux Medical Technology Co., Ltd..
| Plant | City | Device types |
|---|---|---|
| Guangdong MacroLux Medical Technology Co., Ltd. | Dongguan | 9 |
What It Makes
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| CoralWell | FED | 56 |
| LoopView® | EOQ | 15 |
| CoralView® | FGB | 12 |
| SeleneView® | HIH | 9 |
| Power adapter | EOQ | 8 |
| BubbleView® | FAJ | 6 |
| ViewHub | EOQ | 6 |
| Single-Use Biopsy Forceps | HFB | 3 |
| Single-Use Grasping Forceps | FCL | 3 |
| Single-use Endoscopic Scissors | NWW | 3 |
| Single-Use Alligator Grasper | HFB | 3 |
| Single-Use Biopsy Forceps | FCL | 3 |
| Trolley | FOX | 2 |
| Mounting Holder | EOQ | 2 |
| ViewHub® | FGB | 1 |
| HDMI cable | EOQ | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K260516 | 2026-07-20 | FGB | Traditional | This company |
| K260420 | 2026-04-08 | EOQ | Traditional | This company |
| K250452 | 2025-06-02 | FED | Traditional | This company |
| K240978 | 2024-08-16 | HIH | Traditional | This company |
| K240283 | 2024-06-10 | FAJ | Traditional | This company |
| K233779 | 2024-04-05 | EOQ | Traditional | This company |
| K231774 | 2024-01-11 | FGB | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2020 |
|---|---|
| Main products | Single-use electronic endoscopes, Flexible ureteroscopes, Airway management devices |
| Export markets | International |
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.