Standard Instruments GmbH
DE-MF-000013833 · Germany · Karlsruhe
Standard Instruments GmbH is registered in the European database on medical devices as a manufacturer, with 12 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 12 |
|---|
Among these devices, 12 are declared active, 12 with a measuring function.
Devices declared under this manufacturer
- Imphora
- ViMeDat
- ZALT
Catalogue references include SI-SNID10, SI-SNID15, SI-SNIS-S, SI-ZNID-L, SI-ZNIS-M, SI-ZNIS-S.
European nomenclature codes declared: G030799.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 12 |
| 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 | 12 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
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: Neither register. Standard Instruments GmbH was not found in either the U.S. or the Canadian register.