Hermes Medical Solutions AB
SE-MF-000023032 · Sweden · Stockholm
Hermes Medical Solutions AB is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 2 |
|---|---|
| Class IIa | 5 |
Most frequent device types declared: Version 3.0.
Among these devices, 4 are declared active.
Devices declared under this manufacturer
- Hermia
- Hermia Multimodality Viewer
- Hermia Olinda
Catalogue references include 00859873006073, 00859873006172, 00859873006189, 00859873006196, 00859873006219, 00859873006226.
European nomenclature codes declared: Z11029092.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | HERMES MEDICAL SOLUTIONS, AB (SE) · FDA 9710645 |
| Devices in EUDAMED | 7 |
| Country of registration | Sweden |
Device-level evidence
| Devices with a numeric GTIN | 7 |
|---|---|
| Found in the U.S. device database | 6 |
| Share | 85.7 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | HERMES MEDICAL SOLUTIONS, AB |
What it holds in Canada
| Licences on record | 6 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 5 |
| Class 3 devices | 1 |
| First licensed | 2006-11-07 |
Licence types: Single Device (5), Device Family (1).
Licensed under: HERMES DIAGNOSTIC IMAGING SOFTWARE, AFFINITY, HYBRID3D, HYBRID VIEWER, HYBRID RECON, AFFINITY.
North American profile: Both markets. Hermes Medical Solutions AB is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
28620167501-01 | amended | 2028-10-03 |