FDA Registration
Active
🇺🇸 United States
15115001D
Reg #: 1216677
·
FEI: 1216677
·
Expires 2025
Products
1
Proprietary Names
6
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
- K031228
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
15115001D
SynVitro® Hyadase 1511
15115001F
15115001X
SynVitro® Hyadase 15115001
15115001A
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device