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EUDAMED last updated this device on Nov 15, 2024
590426134ELBURPB325MIDGFPB325IIMIDL-4C-90200-I-B37T-N29-Z9-xF1 is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Elbur spółka z ograniczoną odpowiedzialnością spółka komandytowa. Placed on the EU market in Poland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
0590426134157385602PL-MF-000002124No 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.(01)05904261341573
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
1 warning recorded — scroll inside the panel to see all entries.
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.
Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
Primary placement in Poland; available across 2 countries total.
| Country | On market since | Until |
|---|---|---|
| PolandPrimary placement | — | Still on market |
| Finland | — | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
V08060101HOSPITAL/HOME CARE ELECTRIC MEDICAL BEDSPrimary 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 →MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
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 →590426134ELBURPB325IIIG5On the marketPB325IIL-4C-90220-I-N11-Z5-Z9-xF1590426134ELBURPB325IIIG5On the marketPB325IIMIDL-4C-80200-I-B37T-N29-Z9-xF1590426134ELBURPB325MIDGFOn the marketPB325IIMIDL-4C-90200-I-xF1590426134ELBURPB325MIDGFOn the marketPB325IVL-4C-90200-I590426134ELBURPB325IIIG5On the marketPB325IVL-4C-90200-I-B51/2-N335-Z9590426134ELBURPB325IIIG5On the marketNo certificate specifically references this device's Basic UDI-DI.