Data / Medical devices / China / Shandong Int Medical Instruments Co., Ltd
Shandong Int Medical Instruments Co., Ltd: FDA-registered device maker in Rizhao Shandong, China, 2 510(k) clearances
Shandong Int Medical Instruments Co., Ltd is registered with the FDA (registration 3034544377) in Rizhao Shandong, China. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 5, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3034544377
- Address
- No. 188, Fuzhou Road, Rizhao city, Shandong, China., Rizhao Shandong, China, 276803
- Owner or operator
- Shandong INT Medical Instruments Co., Ltd (10091928)
- Roles
- Manufacturer
- First device listed
- December 8, 2024
- Registered through
- 2026
- Brand names listed
- Angiography Injector, High Pressure Tubing, Inflation Device, Manifold, Pressure Bandage, Stopcock
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | DTL | 2 | Manufacturer | accessdata.fda.gov |
| Injector And Syringe, Angiographic | DXT | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Balloon Inflation, Exempt | PTM | 2 | Manufacturer | accessdata.fda.gov |
| Tourniquet, Nonpneumatic | GAX | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 5, 2025 | K244038 | High Pressure Tubing | DXT | Substantially Equivalent | Shandong Int Medical Instruments Co., Ltd. | accessdata.fda.gov |
| December 23, 2024 | K242143 | Angiography Injector | DXT | Substantially Equivalent | Shandong Int Medical Instruments Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Injector And Syringe, Angiographic
- All makers of Syringe, Balloon Inflation, Exempt
- All makers of Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- All makers of Tourniquet, Nonpneumatic
Updated September 5, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.