FDA Registration
Active
🇨🇳 China
Digital Electrocardiograph iE 10
Reg #: 3008457078
·
FEI: 3008457078
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Shenzhen Biocare Bio-Medical Equipment Co., Ltd.
- Registration Number
- 3008457078
- FEI Number
- 3008457078
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- #16-1, Jinhui Road, Jinsha Community, Kengzi Sub-District, Pingshan New District
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K171517
Owner / Operator
- Firm Name
- Shenzhen Biocare Bio-Medical Equipment Co., LTD
- Operator Number
- 10036523
- Address
- #16-1, Jinhui Road, Jinsha Community, Kengzi Sub-District, Pingshan New District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518122
- Country
- CN
- Correspondent
- Hongbo Zhong
US Agent
- Business Name
- Mid-Link International Inc
- Contact Name
- Marco Mu
- Address
- 2219 Rimlang Drive, Suite 301
- City
- Bellingham
- 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 | 2018-01-17 |
Proprietary Names
Digital Electrocardiograph iE 10
Establishment Types
Manufacture Medical Device