Data / Medical devices / China / Shandong Corecare Technology Limited
Shandong Corecare Technology Limited: FDA-registered device maker in Jinan Shandong, China, 2 510(k) clearances
Shandong Corecare Technology Limited is registered with the FDA (registration 3017942784) in Jinan Shandong, China. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 20, 2022. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3017942784
- Address
- Suite 801-2, Incubator Phase I, Innovation Valley Jinan High-Tech Industrial Development Zone, Jinan Shandong, China, 250300
- Owner or operator
- Shandong CoreCare Technology Limited (10079785)
- Roles
- Manufacturer
- First device listed
- December 22, 2020
- Registered through
- 2026
- Brand names listed
- CoreCare Cardiac Monitor, V-Patch Cardiac Monitor, eCordum Cardiac Monitor
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Detector And Alarm, Arrhythmia | DSI | 2 | Manufacturer | accessdata.fda.gov |
| Transmitters And Receivers, Electrocardiograph, Telephone | DXH | 2 | 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 |
|---|---|---|---|---|---|---|
| October 20, 2022 | K222842 | V-Patch Cardiac Monitor | DXH | Substantially Equivalent | Shandong Corecare Technology Limited | accessdata.fda.gov |
| October 30, 2020 | K193296 | eCordum Cardiac Monitor (eCordum CM) | DXH | Substantially Equivalent | Ecordum, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Detector And Alarm, Arrhythmia
- All makers of Transmitters And Receivers, Electrocardiograph, Telephone
Updated October 20, 2022. 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.