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Organization name
UDI-DI code
Reference / catalog number

BL2001.2 BlueLavage® DriveUnit 2.0 — Class IIa MDR

MD Atlas
UTK Solution GmbH

EUDAMED last updated this device on May 13, 2026

BL2001.2 BlueLavage® DriveUnit 2.0

426075025011211BL2D

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: UTK Solution GmbH
UDI-DI code: 04260750250162
Reference / catalog number: 100242

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Manufacturer information

Organization name: UTK Solution GmbH
SRN: DE-MF-000013399
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW020
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Jan 3, 2024	Still on market

Device identification

Trade name: BL2001.2 BlueLavage® DriveUnit 2.0
UDI-DI code: 04260750250162
Basic UDI-DI: 426075025011211BL2D
Reference / catalog number: 100242
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: BL2001.2 BlueLavage® DriveUnit 2.0
Additional information URL: https://bluelavage.com/downloads/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

BL2000.1 BlueLavage® 2.0 with Funnel Tip426075025011211BL2DOn the market BL2000.2 BlueLavage® 2.0 with Longbone Tip426075025011211BL2DOn the market 102127426075025011211BL2DOn the market BL2000.4 BlueLavage® 2.0 with Brush Tip and Funnel Tip426075025011211BL2DOn the market BL2002.02 BlueLavage® Set Dockingstation 2.0 DE with Charger EU426075025011211BL2DOn the market

Certificates

Certificate health across this manufacturer's portfolio.

MDR-0039Issued
Quality management systemNotified body: 1304Expiry: Apr 12, 2031