FDA Registration
Active
🇨🇳 China
electrocardiogram ECG-1112M
Reg #: 3010089768
·
FEI: 3010089768
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SHENZHEN CAREWELL ELECTRONICS CO., LTD.
- Registration Number
- 3010089768
- FEI Number
- 3010089768
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Floor 4, BLD 9, Baiwangxin High-Tech Industrial Park, Songbai Road, Xili Street, Nanshan District
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K113485
Owner / Operator
- Firm Name
- Shenzhen Carewell Electronics Co., Ltd.
- Operator Number
- 10047185
- Address
- Floor 4, BLD 9, Baiwangxin High-Tech Industrial Park, Songbai Road, Xili Street, Nanshan District 518108,Shenzhen, P.R. China
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518108
- Country
- CN
- Correspondent
- Yi Zheng
US Agent
- Business Name
- MID-LINK INTERNATIONAL CO., Ltd
- Contact Name
- Macro Mu
- Address
- 2219 Rimlang Drive, Suite 301 , Bellingham-Barkley Villiage Bakerview, Washington, 98226, UNITED STATES
- City
- Bakerview
- State
- WA
- ZIP
- 98226
- Country
- US
- [email protected]
- Phone
- 702 2095185
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2014-07-15 |
Proprietary Names
electrocardiogram ECG-1112M
Establishment Types
Manufacture Medical Device