Shanghai INT Medical Instruments Co., Ltd.
Registered establishment in Shanghai, China. 10 device types.
Shanghai INT Medical Instruments Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Trocar, Clamp, Vascular and 8 other device types. Its earliest product listing with the FDA dates from 2016.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3009605245 |
| FEI number | 3009605245 |
| Establishment type | Contract manufacturer, Contract steriliser, Repacker / relabeller, Manufacturer |
Location
| City | Shanghai |
|---|---|
| Province | Shanghai |
| Address | 925 Jinyuan Yi Road |
| Postal code | 201803 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | Class 2 | Stopcock, Manifold, Y-Connector Pack YCK119B. | 2016 | 13 |
| Angiography/Angioplasty Kit | Class 2 | 2020 | 3 | |
| Clamp, Vascular | Class 2 | 2026 | 10 | |
| Introducer, Catheter | Class 2 | Micropuncture Kit, Micropuncture Access Kit, Micropuncture Introducer Set, Microintroducer Kit, Microintroducer Set,, Introducer Kit, Introducer Set, Micro Introducer Sheath Set, Introducer Sheath Set | 2026 | 13 |
| Percutaneous Sheath Introducer Kit | Class 2 | KDL Mini Introducer Kit, INT® Mini Introducer Kit | 2021 | 2 |
| Syringe, Balloon Inflation, Exempt | Class 2 | Inflation Device AI25, AI25A, AI30, AI40, ID30, INT-ID-344, INT® Digitalgauge Inflation Device INT-IDA-233., Digitalgauge Inflation Device, INT® Digitalgauge Inflation Device | 2017 | 16 |
| Tourniquet, Nonpneumatic | Class 1 | 2017 | 124 | |
| Tourniquet, Pneumatic | Class 1 | Tourniquet, Pneumatic | 2024 | 21 |
| Trocar | Class 2 | KDL Introducer Needle | 2018 | 9 |
| Wire, Guide, Catheter, Exempt | Class 2 | INT® Torque Device YCK122, Guidewire Torquer, INT® Torque Device | 2024 | 5 |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2006 |
|---|---|
| Employees | 1500+ |
| Main products | Cardiology devices, Neurology products, ENT devices, Orthopedic devices, Urology products |
| Certifications | ISO13485, CE, FDA, NMPA, 73 NMPA certificates, 36 CE certificates, 18 FDA certificates |
| Export markets | Over 70 countries and regions including US and Europe |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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