EC Certification Service GmbH
AT-MF-000006655 · Austria · Sankt Veit an der Glan
EC Certification Service GmbH is registered in the European database on medical devices as a manufacturer, with 63 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 63 |
|---|
Devices declared under this manufacturer
- Premium Line
Showing 12 of 63 declared devices.
Catalogue references include 480-0160-000, 480-0310-100, 661-0151-000, 661-0161-000, 661-0192-100, 661-0201-000.
European nomenclature codes declared: Q010403.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | EC Certification Service GmbH (AT) · FDA 3008796797 |
| Devices in EUDAMED | 63 |
| Country of registration | Austria |
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. EC Certification Service GmbH is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
MDR-0035 | supplemented | 2031-02-03 |