FDA Registration
Active
🇨🇳 China
Accuryn Monitoring System; Accuryn SmartFoley IAP UO Temp Tray System; Accuryn SmartFoley UO Temp Tray System; AccuTab
Reg #: 3011707784
·
FEI: 3011707784
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.
- Registration Number
- 3011707784
- FEI Number
- 3011707784
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Building 2# Hongfeng Road & No.69-71 Hongdou Road, Baimao Industrial Park, Guli Town
- City
- Changshu Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K221020
Owner / Operator
- Firm Name
- ChangShu Rozer Sterilization Technology Co., Ltd.
- Operator Number
- 10049312
- Address
- No.69-71 Hongdou Road, Baimao Industrial Park, Guli Town
- City
- Changshu
- State
- Jiangsu
- Postal Code
- 215532
- Country
- CN
- Correspondent
- Gary Zhu
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Retention Type, Balloon | EZL | Class 2 | Gastroenterology, Urology | No | 2024-06-15 |
| Uroflowmeter | EXY | Class 2 | Gastroenterology, Urology | No | 2024-06-15 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2024-06-15 |
| Intra-Abdominal Pressure Monitoring Device | PHU | Class U | Unknown | No | 2024-06-15 |
Proprietary Names
Accuryn Monitoring System; Accuryn SmartFoley IAP UO Temp Tray System; Accuryn SmartFoley UO Temp Tray System; AccuTab
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)