FDA Registration
Active
🇨🇳 China
Cure Closed System
Reg #: 3006430057
·
FEI: 3006430057
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- INTEGRAL MEDICAL PRODUCTS CO., LTD.
- Registration Number
- 3006430057
- FEI Number
- 3006430057
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No. 77 Zhongshan Road, Yuecheng District
- City
- SHAOXING Zhejiang
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K230400
Owner / Operator
- Firm Name
- INTEGRAL MEDICAL PRODUCTS CO., LTD.
- Operator Number
- 9094212
- Address
- No. 77 Zhongshan Road, Yuecheng District
- City
- Shaoxing
- State
- Zhejiang
- Postal Code
- 312035
- Country
- CN
US Agent
- Business Name
- IRC USA
- Contact Name
- Charles Mack
- Address
- 2950 E Lindrick Dr.
- City
- Chandler
- State
- AZ
- ZIP
- 85249
- Country
- US
- [email protected]
- Phone
- 931 6254938
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Straight | EZD | Class 2 | Gastroenterology, Urology | No | 2024-03-27 |
Proprietary Names
Cure Closed System
Cure Dextra
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)
Manufacture Medical Device for Another Party (Contract Manufacturer)