Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3032859397

FEI Number

3032859397

Entity Name

INNOVEX MEDICAL CO., LTD.

City/State/Country

Shanghai, CN

Establishment Address

2nd Floor, No.17 Building, 315 Qingda Rd, Pudong, 201201 Shanghai, P.R. China, 1st, 2nd Floor, No.14 Building and 3rd, 4th Floor, No.17 Building, 315 Qingda Rd, Pudong, 201201 Shanghai, P.R, Shanghai 201201, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

INNOVEX MEDICAL CO., LTD. (Owner Number: 10092290)

Owner / Operator Contact Address

2nd Floor, No.17 Building, 315 Qingda Rd, Pudong, 201201 Shanghai, P.R. China, 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

Single Use Grasping Forceps(IVX-GF1-1806A, IVX-GF1-1808A, IVX-GF1-1810A, IVX-GF1-1812A) Urological Stone Extraction Baskets(IVX-US-T0810, IVX-US-T0810S, IVX-US-T1110, IVX-US-T1110S) Urological Stone Extraction Baskets(IVX-US-F1110, IVX-US-F1110S, IVX-US-F1110L); Urological Sampler Sets (IVX-NB-150)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PTS	Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt	Gastroenterology, Urology	Class 2	876.1500	2025-02-16
FGO	Dislodger, Stone, Flexible	Gastroenterology, Urology	Class 2	876.4680	2025-04-09
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2024-12-20

Official Correspondent

Alice Wang

US Agent Details

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

Related Public Records

Same Entity

INNOVEX MEDICAL CO., LTD.

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-2013	US Endoscopy Group Inc	2	Endoscopic retrieval device. The disposable Raptor grasping device in intended to retrieve foreign bodies or resected tissue specimens in endoscopic procedures of the upper and lower gastrointestinal tract or biliary tract.

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3013460719	ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD.	Hangzhou Zhejiang, CN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3032859397. Last updated year: 2026. Please use registration number 3032859397 when referencing this establishment in official correspondence.