Data / Medical devices / China / Macrolux Medical Technology Co., Ltd.
Macrolux Medical Technology Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 7 510(k) clearances
Macrolux Medical Technology Co., Ltd. is registered with the FDA (registration 3029929134) in Shenzhen Guangdong, China. It lists 9 device types. The FDA files 7 510(k) clearances under its listings, the newest dated July 20, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3029929134
- Address
- 301, Building 3, NamTai Inno Park In Guang Ming Avenue, Guangming, Shenzhen Guangdong, China, 518107
- Owner or operator
- MacroLux Medical Technology Co., Ltd. (10089857)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- January 16, 2024
- Registered through
- 2026
- Brand names listed
- BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR), BubbleView Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR), CoralView® Single-use Digital Flexible Ureteroscope (U10, U10-B, U10-BR, U20, U20-B, U20-BR), CoralWell, NS-0835B, NS-0840B, NS-0845B, NS-0855B, NS-0935B, NS-0940B, NS-0945B, NS-0955B, NS-1035B, NS-1040B, NS-1045B,, LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG), LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C), LoopView® Single-Use Digital Flexible Bronchoscope (B38-G, B38-CG, B50-G, B50-CG, B58-G, B58-CG),, NS-1055B, NS-1135B, NS-1140B, NS-1145B, NS-1155B, NS-1235B, NS-1240B, NS-1245B, NS-1255B, NS-1335B, NS-1340B, NS-1345B, and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bronchoscope (Flexible Or Rigid) | EOQ | 2 | Manufacturer | accessdata.fda.gov |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | 2 | Manufacturer | accessdata.fda.gov |
| Endoscopic Access Overtube, Gastroenterology-Urology | FED | 2 | Manufacturer | accessdata.fda.gov |
| Forceps, Biopsy, Gynecological | HFB | 1 | Manufacturer | accessdata.fda.gov |
| Forceps, Biopsy, Non-Electric | FCL | 1 | Manufacturer | accessdata.fda.gov |
| Hysteroscope (And Accessories) | HIH | 2 | Manufacturer | accessdata.fda.gov |
| Hysteroscope Accessories | NWW | 1 | Manufacturer | accessdata.fda.gov |
| Stand, Infusion | FOX | 1 | Exporter to the US | accessdata.fda.gov |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 20, 2026 | K260516 | BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR) | FGB | Substantially Equivalent | MacroLux Medical Technology Co., Ltd. | accessdata.fda.gov |
| April 8, 2026 | K260420 | LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG) | EOQ | Substantially Equivalent | MacroLux Medical Technology Co., Ltd. | accessdata.fda.gov |
| June 2, 2025 | K250452 | CoralWell Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0855B, NS-0935B, NS-0940B, NS-0945B, NS-0955B, NS-1035B, NS-1040B, NS-1045B, NS-1055B, NS-1135B, NS-1140B, NS-1145B, NS-1155B, NS-1235B, NS-1240B, NS-1245B, NS-1255B, NS-1335B, NS-1340B, NS-1345B, NS-1355B, NS-1435B, NS-1440B, NS-1445B, NS-1455B) | FED | Substantially Equivalent | MacroLux Medical Technology Co., Ltd. | accessdata.fda.gov |
| August 16, 2024 | K240978 | SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G) | HIH | Substantially Equivalent | MacroLux Medical Technology Co., Ltd. | accessdata.fda.gov |
| June 10, 2024 | K240283 | BubbleView Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR); ViewHub® Video Processor (S13, S13-T, S13-N, S13-S) | FAJ | Substantially Equivalent | MacroLux Medical Technology Co., Ltd. | accessdata.fda.gov |
| April 5, 2024 | K233779 | LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C), ViewHub® Video Processor (S13) | EOQ | Substantially Equivalent | MacroLux Medical Technology Co., Ltd. | accessdata.fda.gov |
| January 11, 2024 | K231774 | CoralView® Single-use Digital Flexible Ureteroscope (U10); CoralView® Single-use Digital Flexible Ureteroscope (U10-B); CoralView® Single-use Digital Flexible Ureteroscope (U10-BR); CoralView® Single-use Digital Flexible Ureteroscope (U20); CoralView® Single-use Digital Flexible Ureteroscope (U20-B); CoralView® Single-use Digital Flexible Ureteroscope (U20-BR) | FGB | Substantially Equivalent | MacroLux Medical Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Forceps, Biopsy, Non-Electric
- All makers of Bronchoscope (Flexible Or Rigid)
- All makers of Ureteroscope And Accessories, Flexible/Rigid
- All makers of Forceps, Biopsy, Gynecological
- All makers of Cystoscope And Accessories, Flexible/Rigid
- All makers of Hysteroscope Accessories
Updated July 20, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.