Remco Italia S.p.A.
Country not established
- Devices
- 3
What Remco Italia S.p.A. makes
Remco Italia S.P.A. manufactures electrocardiograph devices, including single-channel (Carioline), portable Holter monitors (Click Holter), and 12-channel digital electrocardiographs (Elan Digital). These products are designed for continuous or intermittent cardiac rhythm recording and analysis in clinical settings.
The company’s devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The portfolio is authorised for use in the United States, where the manufacturer is based.
Catalogue
Carioline(Electrocardiograph) Ref K852770
Regimes: 510(k) Registry: 510(k)Click Holter Ref K032276
Regimes: 510(k) Registry: 510(k)Elan Digital 12 Channel Electrocardiograph Ref K032200
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Remco Italia S.P.A. have in the registry?
The registry currently lists 3 devices for Remco Italia S.P.A.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Remco Italia S.P.A.'s devices?
Among its 3 most recently registered devices, Remco Italia S.P.A. has devices listed in FDA 510(k) (3 devices).
What risk classes do Remco Italia S.P.A.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Remco Italia S.P.A.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Remco Italia S.P.A. in the registry?
The most recently registered devices listed for Remco Italia S.P.A. include CARIOLINE(ELECTROCARDIOGRAPH), CLICK HOLTER and ELAN DIGITAL 12 CHANNEL ELECTROCARDIOGRAPH.