# Guangdong MacroLux Medical Technology Co., Ltd. (contract manufacturer, Dongguan Guangdong, CN): 6 new FDA device listings, incl. forceps, biopsy, gynecological

**Score:** 70/100

| Field | Value |
|---|---|
| Establishment | Guangdong MacroLux Medical Technology Co., Ltd. |
| Owner / operator | MacroLux Medical Technology Co., Ltd. |
| Role | Contract manufacturer |
| Establishment types | Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Location | Dongguan Guangdong, CN |
| New listings | 6 |
| Devices | Forceps, Biopsy, Gynecological; Forceps, Biopsy, Non-Electric; Cystoscope And Accessories, Flexible/Rigid; Ureteroscope And Accessories, Flexible/Rigid; Hysteroscope Accessories |
| Product codes | HFB, FCL, FAJ, FGB, NWW |
| Device classes | Class I, Class II |
| Medical specialties | Obstetrics/Gynecology, Gastroenterology, Urology |
| Brand names | 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); Single-Use Biopsy Forceps (BF-F-1.8X600, BF-F-1.8X600-G, BF-F-1.8X600-O); Single-Use Grasping Forceps (GF-F-1.8X600, GF-F-1.8X600-G, GF-F-1.8X600-O); 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) |
| First new listing | 2026-05-18 |
| Latest new listing | 2026-08-07 |
| FDA registration number | 3035710892 |
| Registration expires | 2026-12-31 |

## Why this score
- Contract manufacturer or sterilizer adding work.
- 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: 2026-11-04T21:52:36.524Z.
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.