Certificate valid

Snapshot 2026-10-10 · Link to EUDAMED

BL2001.1 DriveUnit

UDI-DI 04260750250094Basic UDI-DI 426075025011211BL2D

Class IIa · MDR · UTK Solution GmbH

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Identification

Model: BlueLavage®
EMDN: V9099
Issuing agency: GS1
Device status: discontinued
Sterile: No
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

MDR-0039

EU quality management system · valid

Notified body: SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ (1304)

Valid from 2026-04-13 · Expiry 2031-04-12

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

Manufacturer

UTK Solution GmbH

SRN DE-MF-000013399

DE · Lüdenscheid

manufacturer

Related UDI-DIs

BL2000.1 BlueLavage® 2.0 with Funnel Tip 04260750250315
BL2000.2 BlueLavage® 2.0 with Longbone Tip 04260750250025
BL2000.3 BlueLavage® 2.0 with Longbone Tip and Funnel Tip 04260750250018
BL2000.4 BlueLavage® 2.0 with Brush Tip and Funnel Tip 04260750250070
BL2001.2 BlueLavage® DriveUnit 2.0 04260750250162
BL2002.02 BlueLavage® Set Dockingstation 2.0 DE with Charger EU 04260750250339
BL2002.02 BlueLavage® Set Dockingstation DE with Charger EU 04260750250100
BL2002.03 BlueLavage® Set Dockingstation EN mit Charger USA/JPN für BlueLavage 04260750250117
BL2003.1 BlueLavage® Brush Tip 04260750250063
BL2004.1 BlueLavage® Longbone Tip 04260750250049
BL2005.1 BlueLavage® Funnel 2.0 04260750250087
BL2006.1 BlueLavage® Funnel Tip 04260750250032

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/bl2001-1-driveunit-0094 · UDI page: /udi/04260750250094

All devices from UTK Solution GmbH

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