macu4 AG
CH-MF-000022125 · Switzerland · Zurich
macu4 AG is registered in the European database on medical devices as a manufacturer, with 14 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 14 |
|---|
Authorised representative in the Union: macu4 GmbH.
Devices declared under this manufacturer
- Explorer™ BALL module small with spacer
- Explorer™ BALL module small without spacer
- Explorer™ BALL module standard with spacer
- Explorer™ BALL module standard without spacer
- Explorer™ BIKE module standard with spacer
- Explorer™ BIKE module standard without spacer
- Explorer™ Clip
- Explorer™ SWIM module small without spacer
- Explorer™ SWIM module standard without spacer
- Explorer™ TWIN module large with spacer
- Explorer™ TWIN module large without spacer
- Explorer™ TWIN module standard with spacer
Showing 12 of 14 declared devices.
Catalogue references include 7649988373213, 7649988373237, 7649988373251, 7649988373282, 7649988989209, 7649988989216.
European nomenclature codes declared: Y99.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | macu4 GmbH (DE) · FDA 3042101018 |
| Devices in EUDAMED | 14 |
| Country of registration | Switzerland |
Device-level evidence
| Devices with a numeric GTIN | 14 |
|---|---|
| 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: United States only. macu4 AG is registered in the United States but was not found in the Canadian register.