Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3035484431

FEI Number

3035484431

Entity Name

Innovex Medical (Malaysia) Sdn.Bhd

City/State/Country

Gelang Patah Johor, MY

Establishment Address

No.4, Jalan Laman Setia 7/5, Taman Laman Setia., Gelang Patah Johor 81500, MY

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Shanghai AnQing Medical Instrument CO., Ltd. (Owner Number: 10058112)

Owner / Operator Contact Address

3rd Floor, No.2 Building,, 366 Huiqing Rd , East Zhangjiang High-Tech Park, Shanghai, CN-SH 201201, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Flexible Ureterorenoscope (US31E-12-EU, US31E-12-US)

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	2022-10-14

Official Correspondent

No official correspondent registered.

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

Shanghai AnQing Medical Instrument 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
3015139943	Shanghai AnQing Medical Instrument Co., Ltd	Shanghai, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K915458	Psi Medical Products, Inc.	URETEROSCOPE	1992-01-30

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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 3035484431. Last updated year: 2026. Please use registration number 3035484431 when referencing this establishment in official correspondence.