Bellco SRL
ItalyFDA applicant, unverified FDA FEI 1000312731
- Devices
- 13
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Bellco SRL makes
Bellco Srl manufactures hemodialysis devices, including the Clearum™ HS family of dialyzers and the RAPIDO hollow-fibre dialyzers. These products are designed for use in renal replacement therapy, providing filtration for patients undergoing hemodialysis. The Clearum HS line includes specific models such as HS 13, HS 15, HS 17, HS 20, and HS 22, each tailored for different patient needs and treatment protocols.
The company’s devices fall under Class II classification in the US regulatory framework, with relevant products listed via the FDA’s 510(k) pathway. These products are intended for commercial distribution within the United States, adhering to regulatory requirements for medical devices in hemodialysis.
Catalogue
Search and filter all 13 devicesCompany details
- FDA FEI number
- 1000312731
- DUNS number
- 338685723
- Address
- via Camurana, 1, Mirandola Modena
- [email protected]
- Phone
- +39053529111
Frequently asked questions
How many devices does Bellco Srl have in the registry?
The registry currently lists 13 devices for Bellco Srl. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bellco Srl's devices?
Among its 13 most recently registered devices, Bellco Srl has devices listed in FDA 510(k) (3 devices) and FDA GUDID (10 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Bellco Srl's devices fall under?
Among its 13 most recently registered devices, the classes recorded for Bellco Srl's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bellco Srl in the registry?
The most recently registered devices listed for Bellco Srl include CLEARUM HS IBP4373, CARPEDIEM IB0595580, 3 L NON STERILE WASTE BAGS IB0507009 and CARPEDIEM IB7010250.