FDA Registration
Active
🇺🇸 United States
10890001A, 10905000A
Reg #: 1216677
·
FEI: 1216677
·
Expires 2025
Products
1
Proprietary Names
9
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
- K991329
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
10890001A, 10905000A
PVP Clinical Grade 10905000
PVP Clinical Grade 1090
10890001D, 10905000D
10890001F, 10905000F
PVP Medium
PVP Clinical Grade
PVP Medium 10890001
PVP Medium 1089
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198