FDA Registration
Active
🇺🇸 United States
10690060F, 10691010F, 10695060F, 10700060F, 10701010F, 10702010F, 10705060F
Reg #: 1216677
·
FEI: 1216677
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- COOPERSURGICAL, INC.
- Registration Number
- 1216677
- FEI Number
- 1216677
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 95 CORPORATE DRIVE
- City
- Trumbull
- State
- CT
- ZIP
- 06611
- Country
- US
Regulatory Submissions
- 510(k) Number
- K991332
Owner / Operator
- Firm Name
- COOPERSURGICAL, INC.
- Operator Number
- 9002384
- Address
- 95 CORPORATE DR., --
- City
- Trumbull
- State
- CT
- Postal Code
- 06611
- Country
- US
- Correspondent
- Mauro Castro
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Media, Reproductive | MQL | Class 2 | Obstetrics/Gynecology | No | 2021-03-12 |
Proprietary Names
10690060F, 10691010F, 10695060F, 10700060F, 10701010F, 10702010F, 10705060F
Sperm Preparation Medium
10690060A, 10691010A, 10695060A, 10700060A, 10701010A, 10702010A, 10705060A
10690060D, 10691010D, 10695060D, 10700060D, 10701010D, 10702010D, 10705060D
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device