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

Milenia QuickLine HIT Control — IVDD — General IVDD

MD Atlas
Milenia Biotec GmbH

EUDAMED last updated this device on May 8, 2026

Milenia QuickLine HIT Control

B-04260177041107

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: 04260177041107
Reference / catalog number: 01513

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

Critical warnings

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

CW167
Wear lab coat and protective gloves

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Mar 17, 2022	May 11, 2026

Device identification

Trade name: Milenia QuickLine HIT Control
UDI-DI code: 04260177041107
Basic UDI-DI: B-04260177041107
Reference / catalog number: 01513
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 HIT Control/STic Expert HIT Control is used for quality control for the corresponding Milenia QuickLine HIT/STic Expert HIT test. The HIT control includes a negative and a positive sample. It is used to determine test validity. The tests are carried out indoors exclusively by laboratory staff.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W010302080501HEMOSTASIS CONTROLS RT & POC

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

Related devices

Milenia QuickLine HITB-04260177041206On the market Milenia QuickLing HITB-04260177041008On the market MQHIT 1B-04260177041305On the market STic Expert HIT ControlB-04260177041152On the market MQL6 1B-04260177042005On 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.