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
Media, Reproductive MQL

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