- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED data as of Jun 25, 2026
EUDAMED last updated this device on Jun 22, 2026
B-Z033204RZ03320 is an IVDD-legacy in vitro diagnostic on the European market. It is classified as IVDD — General. Manufactured by DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.. Placed on the EU market in Austria. Explore certificates, regulatory status and the official record on MD Atlas.
D-Z033204RZ03320D-Z033204R
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA / IFA support is coming.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0102050213FREE BETA HCG (PRENATAL SCREENING)8 warnings recorded — scroll inside the panel to see all entries.
AT-MF-000000254No 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.A mixture of 5-CHLORO-2-METHYL-2H-ISOTHIAZOL-3-ONE and 2-METHYL-2H-ISOTHIAZOL-3-ONE
Primary placement in Austria; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| AustriaPrimary placement | — | Still on market |
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 DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
UDI 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.
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
No certificate specifically references this device's Basic UDI-DI.