Malsch GmbH
DE-MF-000005173 · Germany · Wildeck Obersuhl
Malsch GmbH is registered in the European database on medical devices as a manufacturer, with 26 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 26 |
|---|
Among these devices, 22 are declared active.
Devices declared under this manufacturer
- Care bed AURA
- Care bed AYLEEN Edition XL
- Care bed IMPULSE Edition 100
- Care bed IMPULSE Edition 400 LR
- Care bed IMPULSE Edition 420
- Care bed IMPULSE Edition 420 LR
- Care bed IMPULSE Edition 500
- Hospital bed IMPULSE KL Edition 400-P
- Hospital bed IMPULSE KL Edition XL
- Klinikbett IMPULSE KL Edition 200
- Mechanisches Klinikbett IMPULSE KL-M Edition 200
- Mechanisches Klinikbett IMPULSE KL-M Edition 200-P
Showing 12 of 26 declared devices.
Catalogue references include 000001, 000002, 000003, 000004, 000007, 000014.
European nomenclature codes declared: V08060101, V080602.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | MALSCH GMBH (DE) · FDA 3011670571 |
| Devices in EUDAMED | 26 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 26 |
|---|---|
| Found in the U.S. device database | 1 |
| Share | 3.8 % |
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. Malsch GmbH is registered in the United States but was not found in the Canadian register.