Shandong Int Medical Instruments Co., Ltd.
ChinaFDA applicant, unverified FDA
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Shandong Int Medical Instruments Co., Ltd. makes
Shandong Int Medical Instruments Co., Ltd. manufactures high-pressure tubing and angiography injectors, which are used in interventional radiology procedures to deliver contrast agents and maintain fluid pathways under controlled pressure.
These devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) registry. The company is based in the United States.
Catalogue
High Pressure Tubing Ref K244038
Regimes: 510(k) Registry: 510(k)Angiography Injector Ref K242143
Regimes: 510(k) Registry: 510(k)
FDA establishments
- Shandong Int Medical Instruments Co., Ltd Rizhao Shandong · CN FEI 3034544377
Frequently asked questions
How many devices does Shandong Int Medical Instruments Co., Ltd. have in the registry?
The registry currently lists 2 devices for Shandong Int Medical Instruments Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Shandong Int Medical Instruments Co., Ltd.'s devices?
Among its 2 most recently registered devices, Shandong Int Medical Instruments Co., Ltd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Shandong Int Medical Instruments Co., Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Shandong Int Medical Instruments Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Shandong Int Medical Instruments Co., Ltd. in the registry?
The most recently registered devices listed for Shandong Int Medical Instruments Co., Ltd. include High Pressure Tubing and Angiography Injector.
Which FDA establishments are linked to Shandong Int Medical Instruments Co., Ltd.?
1 FDA establishment is linked to Shandong Int Medical Instruments Co., Ltd. in the registry; they are listed on the company page.