MELAG Medizintechnik GmbH & Co. KG
DE-MF-000006703 · Germany · Berlin
MELAG Medizintechnik GmbH & Co. KG is registered in the European database on medical devices as a manufacturer, with 9 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 3 |
|---|---|
| Class IIb | 6 |
Most frequent device types declared: Careclave, MELAcare, MELAtherm 20, Premium Line, Pro/Prime Line.
Among these devices, 9 are declared active.
Devices declared under this manufacturer
- Careclave 618
- MELAcare 600
- MELAtherm 20 (215)
- MELAtherm 20 (225)
- MELAtherm 20 (235)
- MELAtherm 20 (245)
- Vacuclave 105
- Vacuclave 118
- Vacuclave 550
Catalogue references include ME10105, ME10118, ME10550, ME10600, ME10618, ME20022A50.
European nomenclature codes declared: Z12011301, Z12011305, Z12011301,Z12011305.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 9 |
| 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 | 9 |
|---|---|
| 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. MELAG Medizintechnik GmbH & Co. KG was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HZ 1082891-1 | supplemented | 2026-12-23 |