FDA Registration
Active
🇨🇳 China
sterile urethral catheterization, with or without catheter
Reg #: 3018116884
·
FEI: 3018116884
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ROZER STERILIZATION TECHNOLOGY SHUYANG COMPANY LIMITED
- Registration Number
- 3018116884
- FEI Number
- 3018116884
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No.32 Jinhua Rd.
- City
- Shuyang Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K030712
Owner / Operator
- Firm Name
- Rozer Sterilization Technology Shuyang Company Limited
- Operator Number
- 10079290
- Address
- No.32 Jinhua Rd.,
- City
- Shuyang
- State
- Jiangsu
- Postal Code
- 223600
- Country
- CN
- Correspondent
- Gary ZHU
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | FCM | Class 2 | Gastroenterology, Urology | No | 2020-11-29 |
Proprietary Names
sterile urethral catheterization, with or without catheter
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)