FDA Registration
Active
🇮🇹 Italy
BELLCO Srl
Reg #: 1000312731
·
FEI: 1000312731
·
Expires 2026
Products
5
Proprietary Names
4
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- BELLCO Srl
- Registration Number
- 1000312731
- FEI Number
- 1000312731
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- via Camurana, 1
- City
- Mirandola Modena
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K121198
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 |
|---|---|---|---|---|---|
| Bag, Urine Collection, Leg, For External Use, Non-Sterile | NNW | Class 1 | Gastroenterology, Urology | No | 2024-12-11 |
| Warmer, Thermal, Infusion Fluid | LGZ | Class 2 | General Hospital | No | 2024-07-31 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2024-07-31 |
| Pediatric Hemodialysis System | QIR | Class 2 | Gastroenterology, Urology | No | 2024-12-11 |
| Dialyzer, High Permeability With Or Without Sealed Dialysate System | KDI | Class 2 | Gastroenterology, Urology | No | 2024-07-31 |
Proprietary Names
3L NON-STERILE WASTE BAGS FOR CARPEDIEM US
CARPEDIEM System
Clearum HS dialyzers
Clearum HS 17
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device