FDA Registration
Active
🇨🇳 China
Insight Workstation, Model: iS-PF1, iS-PF2
Reg #: 3013528571
·
FEI: 3013528571
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- SHENZHEN INSIGHTERS MEDICAL TECHNOLOGY CO., LTD.
- Registration Number
- 3013528571
- FEI Number
- 3013528571
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Floor 13th, HTM Building, Ganli Road, Longgang District
- City
- Shenzhen Guangdong
- Country
- CN
Owner / Operator
- Firm Name
- Shenzhen Insighters Medical Technology Co., Ltd.
- Operator Number
- 10053495
- Address
- The 13th floor of Hengtemei Building,Ganli Road No. 3
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518000
- Country
- CN
- Correspondent
- Xiao Hua
US Agent
- Business Name
- IRC USA
- Contact Name
- Charles Mack
- Address
- 2950 E Lindrick Dr
- City
- Chandler
- State
- AZ
- ZIP
- 85249
- Country
- US
- [email protected]
- Phone
- 931 6254938
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2020-04-29 |
Proprietary Names
Insight Workstation, Model: iS-PF1, iS-PF2
Insight Workstation Accessory-Trolley:iS-TC1,iS-TC2
Insight Workstation Accessory-Wireless Module, Connection Cable,Power Adapter
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device