Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009605245

FEI Number

3009605245

Entity Name

Shanghai INT Medical Instruments Co., Ltd.

City/State/Country

Shanghai, CN

Establishment Address

925 Jinyuan Yi Road, Shanghai 201803, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Shanghai INT Medical Instruments Co., Ltd. (Owner Number: 10051494)

Owner / Operator Contact Address

925 Jinyuan Yi Road, Shanghai, CN-SH 201803, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Stopcock, Manifold, Y-Connector Pack YCK119B. TOURNIQUET, PNEUMATIC KDL Introducer Needle KDL Mini Introducer Kit, INT® Mini Introducer Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OEQ	Angiography/Angioplasty Kit	Cardiovascular	Class 2	870.1650	2020-11-03
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2016-03-25
KCY	Tourniquet, Pneumatic	General, Plastic Surgery	Class 1	878.5910	2024-06-18
DRC	Trocar	Cardiovascular	Class 2	870.1390	2018-10-31
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2017-04-18
OFL	Percutaneous Sheath Introducer Kit	Cardiovascular	Class 2	870.1340	2021-06-09
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2026-02-24

Official Correspondent

No official correspondent registered.

US Agent Details

Diana Alpin Email: info@duocarepro.com Phone: (626) 4923094

Related Public Records

Same Entity

Shanghai INT Medical Instruments 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
K915301	Advance Medical Designs, Inc.	ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCK	1992-12-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0026-2020	Merit Medical Systems, Inc.	2	Custom Procedure Kit, Custom Kit, REF/Product Code: K12T-03688, single use, RX Only, Sterile EO, LATEX FREE, UDI: (01)00884450389409

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3002834291	MIAN SHAHID CORP.	MUZAFFAR PUR, SIALKOT Punjab, PK
3007138831	ALLWELL MEDICAL CORPORATION	Raleigh, NC, US
1125782	MERIT MEDICAL SYSTEMS, INC	Chester, VA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009605245. Last updated year: 2026. Please use registration number 3009605245 when referencing this establishment in official correspondence.