Guangdong MacroLux Medical Technology Co., Ltd. (contract manufacturer, Dongguan Guangdong, CN): 7 new FDA device listings, incl. cystoscope and accessories, flexible/rigid
Guangdong MacroLux Medical Technology Co., Ltd. (Dongguan Guangdong): 7 new FDA device listings, incl. cystoscope and accessories, flexible/rigid. Its amount of 7 is top-decile (90th percentile of 2,570 records). Dated 89 days ago, it serves as a historical benchmark. Score 70/100. As of 2026-10-28, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 7 · 90th percentile of 2,570 DeviceEstablishmentPulse records · 7.0x the median
Free preview: all 15 published fields of this record are shown below. Locked: 499 related CN DeviceEstablishmentPulse records and the 5-column CSV export.
| 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 | 7 |
| Devices | Cystoscope And Accessories, Flexible/Rigid; Ureteroscope And Accessories, Flexible/Rigid; Forceps, Biopsy, Gynecological; Bronchoscope (Flexible Or Rigid); Hysteroscope Accessories; Forceps, Biopsy, Non-Electric |
| Product codes | FAJ, FGB, HFB, EOQ, NWW, FCL |
| 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 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); LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG); Single-Use Endoscopic Scissors (PS-S-1.6X380, PS-S-1.6X380-G, PS-S-1.6X380-O); 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) |
| First new listing | 2026-05-07 |
| Latest new listing | 2026-08-07 |
| FDA registration number | 3035710892 |
| Registration expires | 2026-12-31 |
| amount percentile | 90th of 2,570 (median 1, 7.0x median) |
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-08-07
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 28 Oct 2026 20:51:27 GMT
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Peer benchmark and outreach value: Guangdong MacroLux Medical Technology Co., Ltd. and 687 CN peers
- CN DeviceEstablishmentPulse records like this one: 687
- Guangdong MacroLux Medical Technology Co., Ltd.'s amount: 90th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every CN peer: $137,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
70 / 100 Score
- Contract manufacturer or sterilizer adding work.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
What is the DeviceEstablishmentPulse record for Guangdong MacroLux Medical Technology Co., Ltd. in Dongguan Guangdong?
Guangdong MacroLux Medical Technology Co., Ltd. (Dongguan Guangdong, CN), a contract manufacturer, added 7 FDA device listings between 2026-05-07 and 2026-08-07.
How does Guangdong MacroLux Medical Technology Co., Ltd. compare to other DeviceEstablishmentPulse records?
This is a top-decile record: its amount of 7 is 7.0x the median of 1 across 2,570 records. It is 89 days old; check the official source for later updates before acting. Its Score of 70/100 puts it among the stronger signals in this feed.
Guangdong MacroLux Medical Technology Co., Ltd. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Guangdong MacroLux Medical Technology Co., Ltd. | Dongguan Guangdong, CN | 7 | 90th | 2026-08-07 |
| NGInstruments, Inc dba Avalign Cutting Instruments | Warsaw, IN | 4 | 83rd | 2026-10-16 |
| Cook Medical LLC | Bloomington, IN | 4 | 83rd | 2026-10-13 |
| Swiss-American CDMO,LLC | Carrollton, TX | 4 | 83rd | 2026-10-12 |
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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.