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, ECG Smart Sensor Model 353010, ECG Smart Sensor model 353 010, ECG247 Back-end Cloud Service, ECG247 Electrode Patch.
Among these devices, 15 are declared active, 15 with a measuring function.
Devices declared under this manufacturer
- ECG247
- ECG247 Electrode Patch
- ECG247 Electrode patch
- ECG247 Sensore Cardiaco
- ECG247 Smart Heart Sensor
- ECG247 Smart Sensor
- ECG247 Smart Sensor APP
- ECG247 Smart Sensor and Electrode
- ECG247 Software Solution
Showing 12 of 17 declared devices.
Catalogue references include 001, 003, 005, 1-1, 1-2, 2.
European nomenclature codes declared: Z12050403, C020501, Z12050492.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 17 |
| Country of registration | Norway |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 7 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. Appsens AS was not found in either the U.S. or the Canadian register.