Akern Srl
IT-MF-000013092 · Italy · Pisa
Akern Srl is registered in the European database on medical devices as a manufacturer, with 12 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 12 |
|---|
Among these devices, 10 are declared active, 8 with a measuring function.
Devices declared under this manufacturer
- BIA101 BIVA PRO
- BIATRODES
- BIVATRODES
- BODYGRAM HBO
- Bodygram Dashboard
- EFG+
- NUTRILAB PRO
- Nutrilab
- Telelab
Catalogue references include 00BSE, 00EFG+, 00NUTRILAB, 00TELELAB, 0ELB100, 0ELBIVA.
European nomenclature codes declared: Z12099001, C020501, V92.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 12 |
| Country of registration | Italy |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 12 |
|---|---|
| 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. Akern Srl was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
IT345661 | issued | 2030-08-31 |