Novo Nordisk A/S
DK-MF-000002222 · Denmark · Bagsværd
Novo Nordisk A/S is registered in the European database on medical devices as a manufacturer, with 29 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 21 |
|---|---|
| Class IIa | 8 |
Among these devices, 2 are declared sterile, 6 active, 21 with a measuring function.
European nomenclature codes declared: A99, A0101010202.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | NOVO NORDISK A/S (DK) · FDA 9681821 |
| Devices in EUDAMED | 29 |
| Country of registration | Denmark |
Device-level evidence
| Devices with a numeric GTIN | 29 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | NOVO NORDISK A/S |
What it holds in Canada
| Licences on record | 7 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 7 |
| First licensed | 1999-06-28 |
Licence types: Device Family (5), Device Group Family (1), Single Device (1).
Licensed under: NOVOFINE, NOVOPEN 4, NOVOPEN ECHO (INSULIN DELIVERY DEVICE), NOVOPEN 4, NOVOPEN 5, NOVOPEN 6.
North American profile: Both markets. Novo Nordisk A/S is registered in both the United States and Canada.