Shenzhen Carewell Electronics Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 2 device types, 1 product catalogued, 3 clearances.
Shenzhen Carewell Electronics Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Electrocardiograph, Computer, Diagnostic, Programmable. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2014.
Registration
| Registered name | SHENZHEN CAREWELL ELECTRONICS CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3010089768 |
| FEI number | 3010089768 |
| DUNS | 545331373 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 深圳市凯沃尔电子有限公司 |
|---|---|
| Unified social credit code | 9144030074321793X8 |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | Floor 4, BLD 9, Baiwangxin High-Tech Industrial Park, Songbai Road, Xili Street |
| Postal code | 518108 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Computer, Diagnostic, Programmable | Class 2 | Carewell, Model AI-ECG Platform, Programmable Diagnostic Computer | 2019 | 10 |
| Electrocardiograph | Class 2 | Carewell, Model AI-ECG Platform, Programmable Diagnostic Computer, electrocardiogram ECG-1112M | 2014 | 18 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Carewell | DPS | 6 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K200036 | 2020-03-20 | DPS | Traditional | This company |
| K180432 | 2018-11-19 | DQK | Traditional | This company |
| K113485 | 2012-04-25 | DPS | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | AI-ECG systems, Electrocardiographs, Patient monitors, Electro-surgical generators, Veterinary products |
|---|---|
| Certifications | CE, FDA |
| Export markets | 100+ countries |
Nearby Manufacturers
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.