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EUDAMED last updated this device on Nov 6, 2025
590455399301179Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →001 763 is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. 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 →05905386929493Basic 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 →590455399301179001 763UDI 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)05905386929493
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
European Medical Device Nomenclature — the EU product classification assigned to this device.
A03040199INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER3 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 →Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
View in glossary →CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
View in glossary →Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
View in glossary →No certificate specifically references this device's Basic UDI-DI.
Primary placement in Poland; available across 29 countries total.
| Country | On market since | Until |
|---|---|---|
| PolandPrimary placement | Apr 25, 2025 | Still on market |
| Austria | Apr 25, 2025 | Still on market |
| Belgium | Apr 25, 2025 | Still on market |
| Bulgaria | Apr 25, 2025 | Still on market |
| Cyprus | Apr 25, 2025 | Still on market |
| Czechia | Apr 25, 2025 | Still on market |
| Germany | Apr 25, 2025 | Still on market |
| Denmark | Apr 25, 2025 | Still on market |
| Estonia | Apr 25, 2025 | Still on market |
| EL | Apr 25, 2025 | Still on market |
| Spain | Apr 25, 2025 | Still on market |
| Finland | Apr 25, 2025 | Still on market |
| France | Apr 25, 2025 | Still on market |
| Croatia | Apr 25, 2025 | Still on market |
| Hungary | Apr 25, 2025 | Still on market |
| Ireland | Apr 25, 2025 | Still on market |
| Iceland | Apr 25, 2025 | Still on market |
| Italy | Apr 25, 2025 | Still on market |
| Lithuania | Apr 25, 2025 | Still on market |
| Luxembourg | Apr 25, 2025 | Still on market |
| Latvia | Apr 25, 2025 | Still on market |
| Malta | Apr 25, 2025 | Still on market |
| Netherlands | Apr 25, 2025 | Still on market |
| Norway | Apr 25, 2025 | Still on market |
| Portugal | Apr 25, 2025 | Still on market |
| Romania | Apr 25, 2025 | Still on market |
| Sweden | Apr 25, 2025 | Still on market |
| Slovenia | Apr 25, 2025 | Still on market |
| Slovakia | Apr 25, 2025 | 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 →