Schülke & Mayr GmbH
DE-MF-000005701 · Germany · Norderstedt
Schülke & Mayr GmbH is registered in the European database on medical devices as a manufacturer, with 206 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 178 |
|---|---|
| Class IIb | 28 |
Among these devices, 4 are declared sterile.
Devices declared under this manufacturer
- gigasept FF (neu)
- gigasept Instru AF
- gigazyme X-tra
- mikrozid AF liquid
- mikrozid liquid
- mikrozid wipes
- octenilin wound gel
- octenisept gel
- octenisept wound gel
- rotasept
- schülke wipes
- terralin AF wipes
Showing 12 of 206 declared devices.
Catalogue references include 104742, 107427, 109160, 121607, 144807, 70002976.
European nomenclature codes declared: D0799, D99, Z12011385, V9099, Z12019003, D0801.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 206 |
| 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 | 206 |
|---|---|
| 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. Schülke & Mayr GmbH was not found in either the U.S. or the Canadian register.