Data / Medical devices / Italy / HMC Premedical S.p.A.
HMC Premedical S.p.A.: FDA-registered device maker in Medolla Modena, Italy, 1 510(k) clearance
HMC Premedical S.p.A. is registered with the FDA (registration 3012667060) in Medolla Modena, Italy. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 14, 2024. Registered through 2026. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3012667060
- Address
- Via Galileo Galilei, 6, Medolla Modena, Italy, 41036
- Owner or operator
- HMC Group (9041724)
- Roles
- Manufacturer
- First device listed
- October 17, 2024
- Registered through
- 2026
- Brand names listed
- Family of DIMAR DIMAX NIV masks
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Ventilator, Continuous, Facility Use | CBK | 2 | Manufacturer | accessdata.fda.gov |
| Ventilator, Non-Continuous (Respirator) | BZD | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| August 14, 2024 | K232836 | Family of DIMAR DMAX NIV masks | CBK | Substantially Equivalent | Dimar S.P.A. | accessdata.fda.gov |
Compare with other makers
- All makers of Ventilator, Non-Continuous (Respirator)
- All makers of Ventilator, Continuous, Facility Use
Updated August 14, 2024. 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.