FDA Registration
Active
🇺🇸 United States
Genesis Malleable Penile Prosthesis
Reg #: 2125050
·
FEI: 2125050
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- COLOPLAST MANUFACTURING US, LLC
- Registration Number
- 2125050
- FEI Number
- 2125050
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1601 W River Rd N
- City
- MINNEAPOLIS
- State
- MN
- ZIP
- 55411
- Country
- US
Regulatory Submissions
- 510(k) Number
- K040959
Owner / Operator
- Firm Name
- Coloplast Corp.
- Operator Number
- 8010144
- Address
- 1601 West River Road North
- City
- Minneapolis
- State
- MN
- Postal Code
- 55411
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Penile | FAE | Class 2 | Gastroenterology, Urology | No | 2008-01-10 |
Proprietary Names
Genesis Malleable Penile Prosthesis
Establishment Types
Manufacture Medical Device