FDA Registration
Active
🇺🇸 United States
Self-Cath Closed System
Reg #: 3030087693
·
FEI: 3030087693
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Coloplast Manufacturing US, LLC.
- Registration Number
- 3030087693
- FEI Number
- 3030087693
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 4008 Heritage Drive
- City
- Brookshire
- State
- TX
- ZIP
- 77423
- Country
- US
Regulatory Submissions
- 510(k) Number
- K223821
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 |
|---|---|---|---|---|---|
| Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | FCM | Class 2 | Gastroenterology, Urology | No | 2023-08-22 |
Proprietary Names
Self-Cath Closed System
Establishment Types
Repack or Relabel Medical Device