FDA Registration
Active
🇮🇹 Italy
Clearum HS dialyzers
Reg #: 1000312731
·
FEI: 1000312731
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BELLCO Srl
- Registration Number
- 1000312731
- FEI Number
- 1000312731
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- via Camurana, 1
- City
- Mirandola Modena
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K193542
Owner / Operator
- Firm Name
- Mozarc Medical US LLC
- Operator Number
- 10090982
- Address
- 15 Hampshire Street
- City
- Mansfield
- State
- MA
- Postal Code
- 02048
- Country
- US
US Agent
- Business Name
- Mozarc Medical US LLC
- Contact Name
- Carol Ming
- Address
- 15 Hampshire Street
- City
- Mansfield
- State
- MA
- ZIP
- 02048
- Country
- US
- [email protected]
- Phone
- 774 2910767
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dialyzer, High Permeability With Or Without Sealed Dialysate System | KDI | Class 2 | Gastroenterology, Urology | No | 2024-07-31 |
Proprietary Names
Clearum HS dialyzers
Establishment Types
Manufacture Medical Device