Zantomed GmbH
DE-MF-000009550 · Germany · Duisburg
Zantomed GmbH is registered in the European database on medical devices as a manufacturer, with 24 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 24 |
|---|
Among these devices, 7 are declared reusable.
Devices declared under this manufacturer
- M+W Select Mischpistole 10:1/4:1
- OmniDispenser 1:1
- Omnibrush eco gelb
- PLU°LINE Plurabrush eco blau
- PLU°LINE Plurabrush eco gelb
- Smartdent Applikatoren blau
- Smartdent Applikatoren gelb
- Smartdent Applikatoren hell lila ultrafein
- Smartdent Applikatoren lila ultrafein
- Smartdent Applikatoren rot fein
- Zantomed Mischpistole 1:1/2:1
- Zantomed Mischpistole 4:1/10:1
Showing 12 of 24 declared devices.
Catalogue references include 103035, 111355, 111356, 117484, 117516, 117522.
European nomenclature codes declared: Q019006, Q0199.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 24 |
| 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 | 24 |
|---|---|
| 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. Zantomed GmbH was not found in either the U.S. or the Canadian register.