Cryotherm GmbH & Co. KG
DE-MF-000018064 · Germany · Kirchen (Sieg)
Cryotherm GmbH & Co. KG is registered in the European database on medical devices as a manufacturer, with 58 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 58 |
|---|
Among these devices, 57 are declared active.
Devices declared under this manufacturer
- BIOSAFE-view
- BIOSAFE®
- BIOSAFE® 120 MD-smart (120 Volt)
- BIOSAFE® 120 MD-smart (230 Volt)
- BIOSAFE® 220 MD-smart (100 Volt)
- BIOSAFE® 220 MD-smart (120 Volt)
- BIOSAFE® 220 MD-smart (230 Volt)
- BIOSAFE® 2400 MD-smart (100 Volt)
- BIOSAFE® 2400 MD-smart (120 Volt)
- BIOSAFE® 500 MD-smart (120 Volt)
- BIOSAFE® 500 MD-smart (230 Volt)
- BIOSAFE® 800 MD-smart (120 Volt)
Showing 12 of 58 declared devices.
Catalogue references include 78221880, 78221883, 78221884, 78221886, 78221899, 78221902.
European nomenclature codes declared: V0499, V92.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 58 |
| 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 | 58 |
|---|---|
| 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. Cryotherm GmbH & Co. KG was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
7260GB448260310 | issued | 2030-06-30 |