- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Oct 8, 2025
B-05907514643004PRESTIGE 24i HbA1c DIRECT is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by PZ CORMAY Spółka Akcyjna. Placed on the EU market in Poland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
059075146430044-300(01)05907514643004
European Medical Device Nomenclature — the EU product classification assigned to this device.
W01010214GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)1 warning recorded — scroll inside the panel to see all entries.
CW010Primary placement in Poland; available across 1 country total.
Placed on the market in Poland; per-country availability dates not published.
PL-MF-000023053Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
View in glossary →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.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →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.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →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.
View in glossary →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.Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →No certificate specifically references this device's Basic UDI-DI.
B-05907514644230On the marketPRESTIGE 24i GLUCOSE HEXB-05907514642311On the marketPRESTIGE 24i HbA1c DIRECTB-05907514643011On the marketPRESTIGE 24i HDL DIRECTB-05907514641796On the marketPRESTIGE 24i HDL DIRECTB-05907514644797On the marketPRESTIGE 24i IgAB-05907514642717On the market