FDA Registration
Active
🇨🇳 China
ROOE Medical CPR Aid Device, CPR Training Defibrillator CPR Training AED, CPR Training Manikin, Nurse Training Manikin
Reg #: 3014739961
·
FEI: 3014739961
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- JIANGSU ROOE MEDICAL TECHNOLOGY CO., LTD.
- Registration Number
- 3014739961
- FEI Number
- 3014739961
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No. 19, Renmin East Road, Yangshe Town,
- City
- Zhangjiagang City Jiangsu
- Country
- CN
Owner / Operator
- Firm Name
- Jiangsu Rooe Medical Technology Co., Ltd.
- Operator Number
- 10091569
- Address
- No. 19, Renmin East Road, Yangshe Town,
- City
- Zhangjiagang City
- State
- Jiangsu
- Postal Code
- 215600
- Country
- CN
- Correspondent
- DORIS LIU
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cpr Aid Device Without Feedback | PMK | Class 1 | Cardiovascular | No | 2024-10-16 |
Proprietary Names
ROOE Medical CPR Aid Device, CPR Training Defibrillator CPR Training AED, CPR Training Manikin, Nurse Training Manikin
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device