macu4 GmbH
DE-MF-000038447 · Germany · Konstanz
macu4 GmbH is registered in the European database on medical devices as a manufacturer, with 94 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 94 |
|---|
Devices declared under this manufacturer
- Explorer Ball Module, Standard, without Spacer
- Explorer Bike Module, without Spacer
- Explorer Pinch Module, Standard, with Spacer
- Explorer Ring EXP
- Explorer Swim Module, Standard, without Spacer
- Lumo Cuff STD-MED_C
- Lumo Socket B-3
- Lumo Socket C-2
- Lumo Socket D-2
- Lumo Socket D-4
- Lumo Spacer, STD-C
- Lynk Clic Lock Head 70°, FLAT, Black
Showing 12 of 94 declared devices.
Catalogue references include 4262429650020, 4262429650105, 4262429650150, 4262429650297, 4262429650716, 4262429650747.
European nomenclature codes declared: Y0699, Y061809.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | macu4 GmbH (DE) · FDA 3042101018 |
| Devices in EUDAMED | 94 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 94 |
|---|---|
| Found in the U.S. device database | 64 |
| Share | 68.1 % |
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. macu4 GmbH is registered in the United States but was not found in the Canadian register.