Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3040391040

FEI Number

3040391040

Entity Name

GUANGDONG EO MEDICAL TECHNOLOGY CO., LTD

City/State/Country

Dongguan Guangdong, CN

Establishment Address

No.30 Shengtao Road, Zhangyang, Zhangmutou Town,, Dongguan Guangdong 523622, CN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Guangdong EO Medical Technology Co., Ltd (Owner Number: 10093959)

Owner / Operator Contact Address

No.30 Shengtao Road, Zhangyang, Zhangmutou Town,, Dongguan, CN-GD 523622, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2025-08-22
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2025-08-23
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2025-08-23
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2025-08-23
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2025-08-23

Official Correspondent

WU Chaoer

US Agent Details

Cao Richard Email: Richard0925@Gmail.Com Phone: (646) 7153488

Related Public Records

Same Entity

Guangdong EO Medical Technology Co., Ltd

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

View Entity Profile →

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

Similar Registrations

Registration Number	Establishment Name	Location
3032429484	KARL STORZ Endovision, Inc.	Franklin, MA, US
3010273872	Synergy Health AST, SRL	Alajuela, CR
1000121056	Boston Scientific Corporation	Coventry, RI, US
3013992977	OTU Medical Inc	Union City, CA, US
3010202439	Karl Storz Endoscopy-America, Inc.	El Segundo, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3040391040. Last updated year: 2026. Please use registration number 3040391040 when referencing this establishment in official correspondence.