Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3029929134

FEI Number

3029929134

Entity Name

MACROLUX MEDICAL TECHNOLOGY CO., LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

301, Building 3, NamTai Inno Park In Guang Ming Avenue, Guangming, Shenzhen Guangdong 518107, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MacroLux Medical Technology Co., Ltd. (Owner Number: 10089857)

Owner / Operator Contact Address

301, Building 3, NamTai Inno Park In Guang Ming Avenue, Guangming, Shenzhen, CN-GD 518107, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K260420

PMA Number

N/A

All Registered Proprietary Names

Single-Use Endoscopic Scissors (PS-S-1.6X380, PS-S-1.6X380-G, PS-S-1.6X380-O) CoralView® Single-use Digital Flexible Ureteroscope (U10, U10-B, U10-BR, U20, U20-B, U20-BR) ViewHub® Video Processor (S13, S13-T, S13-N, S13-S) BubbleView Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR) ViewHub® Video Processor (S13, S13-T, S13-N, S13-S) 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) SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G) ViewHub® Video Processor (S13, S13-T, S13-N, S13-S) LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NWW	Hysteroscope Accessories	Obstetrics/Gynecology	Class 1	884.1690	2026-05-18
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2024-01-16
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2024-06-12
HFB	Forceps, Biopsy, Gynecological	Obstetrics/Gynecology	Class 1	884.4530	2026-05-18
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2026-05-18
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2024-08-20
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2026-05-07

Official Correspondent

Linbin Ye

US Agent Details

Sarah Galemmo Business: ICAS Biologics Co., Ltd. Email: US.agent@icas.org.cn Phone: (661) 8033155

Related Public Records

Same Entity

MacroLux Medical Technology Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3035710892	Guangdong MacroLux Medical Technology Co., Ltd.	Dongguan Guangdong, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K915458	Psi Medical Products, Inc.	URETEROSCOPE	1992-01-30
K935716	KARL STORZ Endoscopy-America, Inc.	KARL STORZ FIXED MAGNIFICATION TELESCOPE/KS VARIABLE MAGNIFICATION TELESCOPE	1995-11-16
K811059	Pentax Precision Instrument Corp.	PENTAX BRONCHOFIBERSCOPE #FB-15A	1981-05-27
K142934	Covidien	CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved	2015-06-17
K240075	FUJIFILM Healthcare Americas Corporation	FUJIFILM Endoscope Model EB-710XT	2024-02-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0025-2020	AURIS HEALTH INC	2	Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3029929134. Last updated year: 2026. Please use registration number 3029929134 when referencing this establishment in official correspondence.