Shandong Corecare Technology Limited
Registered establishment in Jinan, Shandong, China. 2 device types, 1 clearance.
Shandong Corecare Technology Limited is a manufacturer holding a current FDA establishment registration. The registration covers Detector And Alarm, Arrhythmia, Transmitters And Receivers, Electrocardiograph, Telephone. Its earliest product listing with the FDA dates from 2020.
Registration
| Registered name | SHANDONG CORECARE TECHNOLOGY LIMITED |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3017942784 |
| FEI number | 3017942784 |
| Establishment type | Manufacturer |
Location
| City | Jinan |
|---|---|
| Province | Shandong |
| Address | Suite 801-2, Incubator Phase I, Innovation Valley |
| Postal code | 250300 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Detector And Alarm, Arrhythmia | Class 2 | 2020 | 10 | |
| Transmitters And Receivers, Electrocardiograph, Telephone | Class 2 | eCordum Cardiac Monitor, V-Patch Cardiac Monitor, CoreCare Cardiac Monitor | 2020 | 6 |
Clearances
1 clearance names Shandong Corecare Technology Limited as applicant. 1 is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K222842 | 2022-10-20 | DXH | Traditional | This company |
| K193296 | 2020-10-30 | DXH | Traditional | Ecordum, Inc. |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Biobase Biodustry(Shandong)Co., Ltd. | 70 |
| Labpeak Co., Ltd. | 43 |
| Scitek Global Co., Ltd. | 43 |
| Jinan Babio Biotechnology Co., Ltd. | 25 |
| Shandong Lianfa Medical Plastic Products Co., Ltd. | 3 |
| Dragon Crown Medical Co., Ltd. | 2 |
| Shandong Lening Medical Technology Co., Ltd. | 1 |
| Onehalf Design Co., Ltd. | 1 |
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.