Data / Medical devices / Italy / Mozarc Medical Italy
Mozarc Medical Italy: FDA-registered device maker in Mirandola Modena, Italy, 1 510(k) clearance
Mozarc Medical Italy is registered with the FDA (registration 3043804021) in Mirandola Modena, Italy. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 29, 2020. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3043804021
- Address
- Via Statale Sud N 153/A, Mirandola Modena, Italy, 41037
- Owner or operator
- Mozarc Medical US LLC (10090982)
- Roles
- Specification developer
- First device listed
- December 11, 2024
- Registered through
- 2026
- Brand names listed
- 3L NON-STERILE WASTE BAGS FOR CARPEDIEM US, CARPEDIEM System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bag, Urine Collection, Leg, For External Use, Non-Sterile | NNW | 1 | Specification developer | accessdata.fda.gov |
| Pediatric Hemodialysis System | QIR | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 29, 2020 | DEN180055 | CARPEDIEM System | QIR | Unknown | Bellco Srl (Now Part of Medtronic, Inc) | accessdata.fda.gov |
Compare with other makers
- All makers of Pediatric Hemodialysis System
- All makers of Bag, Urine Collection, Leg, For External Use, Non-Sterile
Updated April 29, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.