Humedics GmbH
DE-MF-000005094 · Germany · Berlin
Humedics GmbH is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 3 |
|---|---|
| Class IIb | 2 |
Most frequent device types declared: FLIP 4.0.
Among these devices, 2 are declared active, 2 with a measuring function.
Devices declared under this manufacturer
- LiMAx
- LiMAx Atemmaske
- LiMAx Breathing Mask Set A
- LiMAx Breathing Mask Set B
- LiMAx Messgerät
Catalogue references include 201002, 201002M, 201002MR, 201040, FLIP4.0.
European nomenclature codes declared: R030199, Z12040103.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 5 |
| 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 | 3 |
|---|---|
| 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. Humedics GmbH was not found in either the U.S. or the Canadian register.