Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

102127 — Class IIa MDR by UTK Solution GmbH

MD Atlas
UTK Solution GmbH

EUDAMED last updated this device on May 12, 2026

102127

426075025011211BL2D

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: UTK Solution GmbH
UDI-DI code: 04260750250018
Reference / catalog number: 102127

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

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

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Sep 30, 2019	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04260750250018
Basic UDI-DI: 426075025011211BL2D
Reference / catalog number: 102127
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: BL2000.3 BlueLavage® 2.0 with Longbone Tip and Funnel Tip
Additional information URL: No additional information URL provided by the manufacturer.
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 BL2000.4 BlueLavage® 2.0 with Brush Tip and Funnel Tip426075025011211BL2DOn the market BL2001.2 BlueLavage® DriveUnit 2.0426075025011211BL2DOn the market BL2002.02 BlueLavage® Set Dockingstation 2.0 DE with Charger EU426075025011211BL2DOn the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.