Appsens AS
NO-MF-000013438 · Norway · Lillesand
Appsens AS is registered in the European database on medical devices as a manufacturer, with 17 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 17 |
|---|
Most frequent device types declared: 353 010, ECG247 model 353 010, ECG Smart Sensor Model 353010, ECG247APP, ECG247 Smart Sensor model 353 010.
Among these devices, 15 are declared active, 15 with a measuring function.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 17 |
| Country of registration | Norway |
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.