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EUDAMED last updated this device on Jun 3, 2026
B-05905386929417Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →006 115 is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by MARGOMED SPÓŁKA AKCYJNA . Placed on the EU market in Poland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
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 →05905386929417Basic 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 →B-05905386929417006 115UDI 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 →(01)05905386929417
European Medical Device Nomenclature — the EU product classification assigned to this device.
W05010203URINE COLLECTION, CONTAINERS3 warnings recorded — scroll inside the panel to see all entries.
CW009CW001CW007Sterile
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 →No certificate specifically references this device's Basic UDI-DI.
Primary placement in Poland; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| PolandPrimary placement | Jan 12, 2024 | Still on market |
PL-MF-000009261Certificate health across this manufacturer's portfolio.
HZ 2631342-1IssuedNotified 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.
View in glossary →