# Macrolux Medical Technology Co., Ltd. (manufacturer, Shenzhen Guangdong, CN): 6 new FDA device listings, incl. cystoscope and accessories, flexible/rigid

**Score:** 75/100

| Field | Value |
|---|---|
| Establishment | Macrolux Medical Technology Co., Ltd. |
| Owner / operator | MacroLux Medical Technology Co., Ltd. |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | Shenzhen Guangdong, CN |
| New listings | 6 |
| Devices | Cystoscope And Accessories, Flexible/Rigid; Ureteroscope And Accessories, Flexible/Rigid; Hysteroscope Accessories; Bronchoscope (Flexible Or Rigid); Forceps, Biopsy, Non-Electric; Forceps, Biopsy, Gynecological |
| Product codes | FAJ, FGB, NWW, EOQ, FCL, HFB |
| Device classes | Class I, Class II |
| Medical specialties | Gastroenterology, Urology, Obstetrics/Gynecology, Ear, Nose, Throat |
| Brand names | BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR); Single-Use Endoscopic Scissors (PS-S-1.6X380, PS-S-1.6X380-G, PS-S-1.6X380-O); LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG); Single-Use Grasping Forceps (GF-F-1.8X600, GF-F-1.8X600-G, GF-F-1.8X600-O); Single-Use Biopsy Forceps (BF-F-1.8X600, BF-F-1.8X600-G, BF-F-1.8X600-O); Single-Use Alligator Grasper (GF-S-1.6X380, GF-S-1.6X380-G, GF-S-1.6X380-O); Single-Use Biopsy Forceps (BF-S-1.6X380, BF-S-1.6X380-G, BF-S-1.6X380-O) |
| First new listing | 2026-05-07 |
| Latest new listing | 2026-08-07 |
| FDA registration number | 3029929134 |
| Registration expires | 2026-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.