FDA Registration
Active
🇨🇳 China
Mask, Oxygen -Oxygen Mask, Rebreathing and Non-Rebreathing, Tracheostomy Mask, Aerosol Mask,
Reg #: 3012002722
·
FEI: 3012002722
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- PRO-MED (WUXI)IMP.& EXP.CO.,LTD.
- Registration Number
- 3012002722
- FEI Number
- 3012002722
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No.282 Changjiang North Rd, Xinwu District,
- City
- Wuxi Jiangsu
- Country
- CN
Owner / Operator
- Firm Name
- Pro-Med (Wuxi)Imp.& Exp.Co.,Ltd.
- Operator Number
- 10085601
- Address
- No.282 Changjiang North Rd, Xinwu District,
- City
- Wuxi
- State
- Jiangsu
- Postal Code
- 214000
- Country
- CN
- Correspondent
- Yong an Zhao
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 |
|---|---|---|---|---|---|
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2022-07-08 |
Proprietary Names
Mask, Oxygen -Oxygen Mask, Rebreathing and Non-Rebreathing, Tracheostomy Mask, Aerosol Mask,
Continuous Positive Airway Pressure Mask, Nasal Oxygen Cannulas, Oxygen Tubing, CO2 Samping Cannule
Establishment Types
Export Device to the United States But Perform No Other Operation on Device