Data / Medical devices / Italy / Cardioline S.P.A.
Cardioline S.P.A.: FDA-registered device maker in Trento, Italy, 2 510(k) clearances
Cardioline S.P.A. is registered with the FDA (registration 3009735945) in Trento, Italy. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 15, 2023. Registered through 2027. FDA data exported November 2, 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
- 3009735945
- Address
- Via Linz 151, Trento, Italy, 38121
- Owner or operator
- CARDIOLINE SPA (10041348)
- Roles
- Manufacturer
- First device listed
- November 25, 2016
- Registered through
- 2027
- Brand names listed
- HD+12, PATIENT CABLE PLUG 10 WIRES AHA FOR HD+ ORANGE, PATIENT CABLE SNAP 10 WIRES AHA FOR HD+, PATIENT CABLE SNAP 10 WIRES IEC FOR HD+ ORANGE, touchECG Windows
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrocardiograph | DPS | 2 | Manufacturer | accessdata.fda.gov |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | 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 |
|---|---|---|---|---|---|---|
| May 15, 2023 | K220526 | HD+12, HD+15 | DRG | Substantially Equivalent | Cardioline S.P.A | accessdata.fda.gov |
| November 2, 2016 | K160746 | CARDIOLINE touchECG | DPS | Substantially Equivalent | Cardioline S.P.A | accessdata.fda.gov |
Compare with other makers
- All makers of Transmitters And Receivers, Physiological Signal, Radiofrequency
- All makers of Electrocardiograph
Updated May 15, 2023. 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.