FDA Registration
Active
🇺🇸 United States
12284001A, 12295002A
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
- K100367
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
12284001A, 12295002A
12284001F, 12295002F
Medicult Vitrification Cooling and Warming
12284001D, 12295002D
12284001 and 12295002 Medicult Vitrification Cooling and Warming
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device