FDA Registration
Active
🇺🇸 United States
10300060F, 10301010F, 10305060F, 10310060F, 10311010F, 10315060F
Reg #: 1216677
·
FEI: 1216677
·
Expires 2025
Products
1
Proprietary Names
5
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
- K991279
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
10300060F, 10301010F, 10305060F, 10310060F, 10311010F, 10315060F
10300060, 10301010, 10305060, 10310060, 10311010, 10315060
Universal IVF Medium
10300060D, 10301010D, 10305060D, 10310060D, 10311010D, 10315060D
10300060A, 10301010A, 10305060A, 10310060A, 10311010A, 10315060A
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device