Shandong INT Medical Instruments Co., Ltd.
Registered establishment in Rizhao, Shandong, China. 4 device types, 2 clearances.
Shandong INT Medical Instruments Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Tourniquet, Nonpneumatic, Injector And Syringe, Angiographic and 2 other device types. Its earliest product listing with the FDA dates from 2024.
4device types registered with the FDA
2510(k) clearances
Registration
| Registered name | SHANDONG INT MEDICAL INSTRUMENTS CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3034544377 |
| FEI number | 3034544377 |
| Establishment type | Manufacturer |
Location
| City | Rizhao |
|---|---|
| Province | Shandong |
| Address | No. 188, Fuzhou Road, Rizhao city, Shandong, China. |
| Postal code | 276803 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | Class 2 | Manifold, Stopcock | 2025 | 13 |
| Injector And Syringe, Angiographic | Class 2 | High Pressure Tubing, Angiography Injector | 2025 | 15 |
| Syringe, Balloon Inflation, Exempt | Class 2 | Inflation Device | 2025 | 16 |
| Tourniquet, Nonpneumatic | Class 1 | Pressure Bandage | 2024 | 124 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K244038 | 2025-09-05 | DXT | Traditional | This company |
| K242143 | 2024-12-23 | DXT | Traditional | This company |
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 solutions, Orthopedic intervention kits, Urology equipment |
| Certifications | ISO13485, CE, FDA, 73 NMPA certificates, 36 CE certificates |
| Export markets | Over 70 countries including US and Europe |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Rizhao Sanqi Medical & Health Articles Co., Ltd. | 18 |
| Shandong Huge Dental Material Corporation | 17 |
| Rizhao Huge Biomaterials Company, Ltd. | 7 |
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.
The manufacturer named here can complete this record.