Macrolux Medical Technology Co., Ltd.
Shenzhen Guangdong, CN
MACROLUX MEDICAL TECHNOLOGY CO., LTD. appears in FDA device records in Shenzhen Guangdong, CN. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Macrolux Medical Technology Co., Ltd. between 2024 and 2026. The busiest year on record is 2024, with 4. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2024 | 4 |
| 2025 | 1 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260516 | BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR) | FGB | Substantially Equivalent | |
| K260420 | LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG) | EOQ | Substantially Equivalent | |
| 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 | |
| K240978 | SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G) | HIH | Substantially Equivalent | |
| 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 | |
| K233779 | LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C), ViewHub® Video Processor (S13) | EOQ | Substantially Equivalent | |
| 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 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3029929134 | 3029929134 | MACROLUX MEDICAL TECHNOLOGY CO., LTD. | 301, Building 3, NamTai Inno Park In Guang Ming Avenue, Guangming, Shenzhen Guangdong 518107 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- EOQBronchoscope (Flexible Or Rigid)
- FAJCystoscope And Accessories, Flexible/Rigid
- FEDEndoscopic Access Overtube, Gastroenterology-Urology
- HFBForceps, Biopsy, Gynecological
- FCLForceps, Biopsy, Non-Electric
- HIHHysteroscope (And Accessories)
- NWWHysteroscope Accessories
- FOXStand, Infusion
- FGBUreteroscope And Accessories, Flexible/Rigid
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain