Sivantos GmbH
DE-MF-000014326 · Germany · Erlangen
Sivantos GmbH is registered in the European database on medical devices as a manufacturer, with 802 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 802 |
|---|
Most frequent device types declared: BTE, CUSTOM, INSTANT FIT, RIC, SLIM RIC.
Among these devices, 802 are declared active.
Devices declared under this manufacturer
- C_ITE AMPLI-MINI 10 58C AS
- C_ITE STERLING 60 6C ITC DIR,N4
- C_ITE STERLING 80 6C ITE (N)
- C_ITE VIO E212 CIC
- HA AB HORIZON 5X RIC-S BLK BLKG
- HA AMPLI-CONNECT R 312T 3MC SB
- HA EMERALD S 20 E1 BRN
- HA M-CORE R-LI 30 DBR
- HA M-CORE R-LI 40 BG
- HA M-CORE R-LI SDEMO GNT
- HA MOSAIC M 20 E1 BG
- HA MOSAIC P 80 6C SLV
Showing 12 of 802 declared devices.
Catalogue references include 10941089, 10941680, 10943788, 10951511, 10964066, 10967874.
European nomenclature codes declared: Y2145060102, Y2145060201, Y2145060101, Y2145060202, Y214599.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Sivantos GmbH (DE) · FDA 3005019184 |
| Devices in EUDAMED | 802 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 802 |
|---|---|
| Found in the U.S. device database | 634 |
| Share | 79.1 % |
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. Sivantos GmbH is registered in the United States but was not found in the Canadian register.