Signia GmbH
DE-MF-000017173 · Germany · Erlangen
Signia GmbH is registered in the European database on medical devices as a manufacturer, with 749 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 749 |
|---|
Most frequent device types declared: BTE, CUSTOM, INSTANT FIT, RIC, SLIM RIC.
Among these devices, 749 are declared active.
Devices declared under this manufacturer
- HA CONTRAST HP+ SLV
- HA CONTRAST R+ BG
- HA DEMO INTUIS 3 RIC 312 BG
- HA MOTION S 2PX BG
- HA MOTION SA 7PX PRL
- HA PURE 3PX SB
- HA PURE 5PX GR
- HA PURE CHARGE&GO 2X SLH
- HA PURE CHARGE&GO 3X RGD
- HA PURE CHARGE&GO 5X BG
- HA PURE+ 7PX GB
- HA STYLETTO 7X S SNW SNWG
Showing 12 of 749 declared devices.
Catalogue references include 10933858, 10933866, 10934213, 10934622, 10947517, 10963588.
European nomenclature codes declared: Y2145060102, Y2145060101, Y2145060201, Y214599, Y2145060202.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 749 |
| Country of registration | Germany |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 749 |
|---|---|
| Found in the U.S. device database | 682 |
| Share | 91.1 % |
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: Neither register. Signia GmbH was not found in either the U.S. or the Canadian register.