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DE-MF-000025590HumaLyzer 4000 is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by Human Gesellschaft für Biochemica und Diagnostica mbH. Placed on the EU market in Netherlands. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Apr 8, 2026
04033145CC18250DZPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)04033145192305
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
Primary placement in Netherlands; available across 13 countries total.
| Country | On market since | Until |
|---|---|---|
| NetherlandsPrimary placement | — | Still on market |
| Belgium | — | Still on market |
| Cyprus | — | Still on market |
| EL | — | Still on market |
| Spain | — | Still on market |
| France | — | Still on market |
| Croatia | — | Still on market |
| Ireland | — | Still on market |
| Liechtenstein | — | Still on market |
| Luxembourg | — | Still on market |
| Malta | — | Still on market |
| Poland | — | Still on market |
| Türkiye | — | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
04033145192305Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
04033145CC18250DZ18250UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
IVDR risk classes
IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0201010101CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)No certificate specifically references this device's Basic UDI-DI.
Certificate health across this manufacturer's portfolio.
D1030000098SupplementedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
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