Odin Medical Limited
GB-MF-000026653 · United Kingdom · London
Odin Medical Limited is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 6 |
|---|
Among these devices, 6 are declared active.
Authorised representative in the Union: Emergo Europe B.V..
Devices declared under this manufacturer
- CADDIE
- CADDIE PLUS
- CADU
- SMARTIBD
Catalogue references include CADDIE, CADDIE PLUS, CADU, SMARTIBD.
European nomenclature codes declared: G99.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | ODIN MEDICAL LIMITED (GB) · FDA 3031983124 |
| Devices in EUDAMED | 6 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 6 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | ODIN MEDICAL LIMITED |
What it holds in Canada
| Licences on record | 3 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 3 |
| First licensed | 2026-07-06 |
Licence types: Single Device (3).
Licensed under: SMARTIBD, CADDIE, CADU.
North American profile: Both markets. Odin Medical Limited is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
Z-23-016-S-IX-E | issued | 2029-07-29 |