FDA Registration
Active
🇨🇳 China
ventilator, non-continuous (respirator)
Reg #: 3010440667
·
FEI: 3010440667
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SYSMED (CHINA) CO., LTD
- Registration Number
- 3010440667
- FEI Number
- 3010440667
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No. 299, Baita Third Street, Hunnan District, Shenyang, Liaoning, 110169, China
- City
- Shenyang Liaoning
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K192177
Owner / Operator
- Firm Name
- SYSMED (CHINA) CO., LTD
- Operator Number
- 10059312
- Address
- No. 299, Baita Third Street, Hunnan District
- City
- Shenyang
- State
- Liaoning
- Postal Code
- 110169
- Country
- CN
- Correspondent
- Liang Kong
US Agent
- Business Name
- Hlongmed International Ltd.
- Contact Name
- Anny Zhao
- Address
- 1312 17th Street#692 Denver, CO 80202
- City
- Denver
- State
- CO
- ZIP
- 80202
- Country
- US
- [email protected]
- Phone
- 503 3344880
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ventilator, Non-Continuous (Respirator) | BZD | Class 2 | Anesthesiology | No | 2020-12-03 |
Proprietary Names
ventilator, non-continuous (respirator)
Establishment Types
Manufacture Medical Device