SIGVARIS AG
CH-MF-000015565 · Switzerland · St. Gallen
SIGVARIS AG is registered in the European database on medical devices as a manufacturer, with 21 743 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 21 743 |
|---|
Most frequent device types declared: DELILAH, Dynaven CLASSIC, Essential COMFORTABLE, Essential THERMOREGULATING, HIGHLIGHT MARINIERE.
Among these devices, 694 are declared with a measuring function.
Authorised representative in the Union: Sigvaris GmbH.
Devices declared under this manufacturer
- Active MASCULINE
- DELILAH
- Dynaven CLASSIC
- Essential CLASSICAL
- Essential COMFORTABLE
- Essential THERMOREGULATING
- HIGHLIGHT MARINIERE
- HIGHLIGHT for women
- Professional
- Specialities ARM SLEEVES TRADITIONAL
- Specialities THROMBO X
- Specialities TRADITIONAL
Showing 12 of 21 743 declared devices.
Catalogue references include 314924, 38911, 43674, 66024, 67143, 71049.
European nomenclature codes declared: M030405.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | SIGVARIS AG (CH) · FDA 8031005 |
| Devices in EUDAMED | 21 743 |
| Country of registration | Switzerland |
Device-level evidence
| Devices with a numeric GTIN | 21 743 |
|---|---|
| Found in the U.S. device database | 646 |
| Share | 3.0 % |
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: United States only. SIGVARIS AG is registered in the United States but was not found in the Canadian register.