Shandong Corecare Technology Limited
ChinaFDA applicant, unverified FDA FEI 3017942784
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Shandong Corecare Technology Limited makes
Shandong Corecare Technology Limited manufactures the V-Patch Cardiac Monitor, a wearable device designed for continuous, non-invasive cardiac monitoring. It is intended for real-time electrocardiogram (ECG) recording and remote patient monitoring, supporting early detection of arrhythmias and other cardiac events.
The V-Patch Cardiac Monitor is classified as a Class II medical device under FDA regulations and is listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Catalogue
V-Patch Cardiac Monitor Ref K222842
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3017942784
- Address
- Suite 801-2, Incubator Phase I, Innovation Valley, Jinan Shandong
Frequently asked questions
How many devices does Shandong Corecare Technology Limited have in the registry?
The registry currently lists 1 device for Shandong Corecare Technology Limited. Devices recorded under merged duplicate company entries are counted once.
Which registries list Shandong Corecare Technology Limited's devices?
Among its 1 most recently registered device, Shandong Corecare Technology Limited has devices listed in FDA 510(k) (1 device).
What risk classes do Shandong Corecare Technology Limited's devices fall under?
Among its 1 most recently registered device, the classes recorded for Shandong Corecare Technology Limited's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Shandong Corecare Technology Limited in the registry?
The most recently registered devices listed for Shandong Corecare Technology Limited include V-Patch Cardiac Monitor.