FDA Registration
Active
🇨🇳 China
Fingertip Pulse Oximeter YM101
Reg #: 3017953405
·
FEI: 3017953405
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SHENZHEN HUAYAN E-COMMERCE CO., LTD.
- Registration Number
- 3017953405
- FEI Number
- 3017953405
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- A803, 8th Floor, Block A, Rongde Times Square, Henggang Street, Longgang District
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K191430
Owner / Operator
- Firm Name
- Shenzhen Huayan E-commerce Co., Ltd.
- Operator Number
- 10079753
- Address
- A803, 8th Floor, Block A, Rongde Times Square, Henggang Street, Longgang District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518115
- Country
- CN
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2020-12-22 |
Proprietary Names
Fingertip Pulse Oximeter YM101
Establishment Types
Export Device to the United States But Perform No Other Operation on Device