UTK Solution GmbH
DE-MF-000013399 · Germany · Lüdenscheid
UTK Solution GmbH is registered in the European database on medical devices as a manufacturer, with 13 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 13 |
|---|
Most frequent device types declared: BlueLavage®.
Among these devices, 8 are declared sterile.
Devices declared under this manufacturer
- BL2000.1 BlueLavage® 2.0 with Funnel Tip
- BL2000.2 BlueLavage® 2.0 with Longbone Tip
- BL2000.3 BlueLavage® 2.0 with Longbone Tip and Funnel Tip
- BL2000.4 BlueLavage® 2.0 with Brush Tip and Funnel Tip
- BL2001.1 DriveUnit
- BL2001.2 BlueLavage® DriveUnit 2.0
- BL2002.02 BlueLavage® Set Dockingstation 2.0 DE with Charger EU
- BL2002.02 BlueLavage® Set Dockingstation DE with Charger EU
- BL2002.03 BlueLavage® Set Dockingstation EN mit Charger USA/JPN für Bl
- BL2003.1 BlueLavage® Brush Tip
- BL2004.1 BlueLavage® Longbone Tip
- BL2005.1 BlueLavage® Funnel 2.0
Showing 12 of 13 declared devices.
Catalogue references include 100242, 101297, 101298, 101299, 101300, 102084.
European nomenclature codes declared: V9099.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 13 |
| 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 | 13 |
|---|---|
| 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. UTK Solution GmbH was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
MDR-0039 | issued | 2031-04-12 |