FDA Registration
Active
🇨🇳 China
Inflation Syringe for Rectal Balloon
Reg #: 9616410
·
FEI: 3003413553
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- KOO MEDICAL EQUIPMENT (SHANGHAI) CO. LTD.
- Registration Number
- 9616410
- FEI Number
- 3003413553
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 100 Zhongde Road, Building No.6, Xiaokunshan Town
- City
- Songjiang Shanghai
- Country
- CN
Owner / Operator
- Firm Name
- KOO MFG, INC.
- Operator Number
- 9012237
- Address
- 100 Zhongde Road, Dakun Indurstrial Park
- City
- Songjiang
- State
- Shanghai
- Postal Code
- 201613
- Country
- CN
- Correspondent
- CHRISTOPHER - KOO
US Agent
- Business Name
- Promedic, LLC
- Contact Name
- Matt Dryden
- Address
- 131 Bay Point Dr NE
- City
- Saint Petersburg
- State
- FL
- ZIP
- 33704
- Country
- US
- [email protected]
- Phone
- 239 3076063
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2006-04-27 |
Proprietary Names
Inflation Syringe for Rectal Balloon
MASK INFLATION BULB
BULB SYRINGES
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)