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Organization name
UDI-DI code
Reference / catalog number

MQL6 1 — IVDD — General IVDD by Milenia Biotec GmbH

MD Atlas
Milenia Biotec GmbH

EUDAMED last updated this device on May 8, 2026

MQL6 1

B-04260177042005

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Milenia Biotec GmbH
UDI-DI code: 04260177042005
Reference / catalog number: MQL6 1

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Manufacturer information

Organization name: Milenia Biotec GmbH
SRN: DE-MF-000028733
Manufacturer status: Active

Critical warnings

4 warnings recorded — scroll inside the panel to see all entries.

CW010
Read this instruction manual carefully before performing the assay. Follow them step by step.
CW267
The reagents provided in these kits contain materials of human and/or animal origin. Whenever human blood product is required for the preparation of these reagents, approved methods are used to test the blood for the antibodies to HIV 1, HIV 2 and HCV, and for hepatitis B surface antigen, and results are found to be negative. However, no test method can offer complete assurance that infectious agents are absent. Therefore, users of reagents of these types must exercise extreme care in full compliance with safety precautions in the manipulation of these biological materials as if they were infectious.
CW007
Do not use Test Unit if foil pouch is damaged!
CW132
Material Safety Data Sheets are available on request (see also www.milenia-biotec.com).

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Mar 2, 2011	May 11, 2026

Device identification

Trade name: not provided
UDI-DI code: 04260177042005
Basic UDI-DI: B-04260177042005
Reference / catalog number: MQL6 1
Issuing entity: GS1

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The Milenia QuickLine IL-6 Test is an in vitro diagnostic lateral flow immunoassay for the semi-quantitative detection of human interleukin 6 in serum, plasma and amniotic fluid.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W01030609INTERLEUKIN 6 (IL-6)

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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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.