Cortrium ApS
DK-MF-000007827 · Denmark · Taastrup
Cortrium ApS is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 6 |
|---|
Among these devices, 6 are declared active, 4 with a measuring function.
Devices declared under this manufacturer
- C3+ Holter Monitor
- C3w Adapter
- C3w Holter Monitor
- Cortrium Apex
Catalogue references include 40005, 40006, 50002, 50002_a, Cortrium Apex.
European nomenclature codes declared: Z12050403, Z12050392, A070199.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 6 |
| Country of registration | Denmark |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 4 |
|---|---|
| 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. Cortrium ApS was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G10 098327 0006 | issued | 2029-06-24 |