Kluba Medical GmbH
DE-MF-000005421 · Germany · Düsseldorf
Kluba Medical GmbH is registered in the European database on medical devices as a manufacturer, with 46 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 46 |
|---|
Most frequent device types declared: Sizes S-L.
Among these devices, 1 are declared sterile.
Devices declared under this manufacturer
- Babykopfschutz Alvibino Starfant
- Medibino - changeable cover Tencel rose
- Medibino - the baby head guard sweat grey
- Medibino - the baby head guard white/grey
- Medibino / Alvibino
- Medibino baby head guard - changeable cover Tencel grey
- Medibino-the baby head guard blue
- MedibinoNEO Disposable Cover cotton knit WITHOUT soft granules - colou
- MedibinoNEO cover GOTS organic cotton with hotel closure - Size L - PU
- MedibinoNEO cover GOTS organic cotton with hotel closure - Size L - un
- MedibinoNEO disposable Cover cotton knit WITHOUT soft granules - colou
- MedibinoNEO disposable cover cotton knit WITH soft granules - colour c
Showing 12 of 46 declared devices.
Catalogue references include 23021703-B, 23021703-R, 23021704-R, 24021703-M, 27021703-M, 52021703-S.
European nomenclature codes declared: V028099.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 46 |
| 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 | 46 |
|---|---|
| Found in the U.S. device database | 18 |
| Share | 39.1 % |
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: Neither register. Kluba Medical GmbH was not found in either the U.S. or the Canadian register.