Cardioline S.p.A.
ItalyFDA applicant, unverified FDA
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Cardioline S.p.A. makes
Cardioline S.P.A manufactures HD+12 and HD+15, which appear to be electrocardiogram (ECG) devices designed for cardiac monitoring and diagnostic purposes.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
HD+12, HD+15 Ref K220526
Regimes: 510(k) Registry: 510(k)
FDA establishments
- Cardioline S.P.A. TRENTO · IT FEI 3009735945
Frequently asked questions
How many devices does Cardioline S.P.A have in the registry?
The registry currently lists 1 device for Cardioline S.P.A. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cardioline S.P.A's devices?
Among its 1 most recently registered device, Cardioline S.P.A has devices listed in FDA 510(k) (1 device).
What risk classes do Cardioline S.P.A's devices fall under?
Among its 1 most recently registered device, the classes recorded for Cardioline S.P.A's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cardioline S.P.A in the registry?
The most recently registered devices listed for Cardioline S.P.A include HD+12, HD+15.
Which FDA establishments are linked to Cardioline S.P.A?
1 FDA establishment is linked to Cardioline S.P.A in the registry; they are listed on the company page.