FDA Registration
Active
🇨🇳 China
Disposable Endoscope Valves Set A
Reg #: 3011707784
·
FEI: 3011707784
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
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
- K151714
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 |
|---|---|---|---|---|---|
| Endoscope Channel Accessory | ODC | Class 2 | Gastroenterology, Urology | No | 2018-11-25 |
Proprietary Names
Disposable Endoscope Valves Set A
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)