FDA Registration
Active
🇨🇳 China
Accuryn Monitoring System; Accuryn SmartFoley IAP UO Temp Tray System; Accuryn SmartFoley UO Temp Tray System;AccuTab
Reg #: 3015337348
·
FEI: 3015337348
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Primecare Medical (Suzhou) Co.,Ltd.
- Registration Number
- 3015337348
- FEI Number
- 3015337348
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Building A1/A4, No. 2 Zengfu Road, Guli Development Zone, 215532 Changshu City, Jiangshu Province, PEOPLE'S REPUBLIC OF CHINA
- City
- Changshu Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K221020
Owner / Operator
- Firm Name
- Primecare Medical (Suzhou) Co.,Ltd.
- Operator Number
- 10059848
- Address
- Building A1/A4, No. 2 Zengfu Road, Guli Development Zone, 215532 Changshu City
- City
- Changshu
- State
- Jiangsu
- Postal Code
- 215532
- Country
- CN
- Correspondent
- Juanjuan Zhang
US Agent
- Business Name
- Osmunda Technology Co, Ltd.
- Contact Name
- Cancan Huang
- Address
- 949 White River Dr Allen
- City
- Allen
- State
- TX
- ZIP
- 75013
- Country
- US
- [email protected]
- Phone
- 858 3571157
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Uroflowmeter | EXY | Class 2 | Gastroenterology, Urology | No | 2023-02-27 |
| Catheter, Retention Type, Balloon | EZL | Class 2 | Gastroenterology, Urology | No | 2023-02-27 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2023-02-27 |
| Intra-Abdominal Pressure Monitoring Device | PHU | Class U | Unknown | No | 2023-02-27 |
Proprietary Names
Accuryn Monitoring System; Accuryn SmartFoley IAP UO Temp Tray System; Accuryn SmartFoley UO Temp Tray System;AccuTab
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)