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EUDAMED last updated this device on Jul 16, 2025
5999862705WND01UGElysium Puki Muki szélcső csecsemőknek is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Elysium Laboratories Kft.. Placed on the EU market in Hungary. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
0599986270517610002(01)05999862705176
European Medical Device Nomenclature — the EU product classification assigned to this device.
T04010103INCONTINENCE NAPPIES WITH INTEGRATED FIXING SYSTEM1 warning recorded — scroll inside the panel to see all entries.
- Ne használja a Puki Mukit 24 órán belül 4 alkalomnál többször! - Ne tolja a Puki Mukit 2 cm-nél mélyebbre! - Ne hagyja a szélcsövet a gyermek végbélnyílásában! - A szélcső kizárólag végbélben és kizárólag a keskenyebbik végét bedugva használható! - Szélcsövezés közben soha ne hagyja magára a csecsemőt! - Sérülések, balesetek elkerülése érdekében feltétlenül tartsa be a fenti óvintézkedéseket! - A nem rendeltetésszerű használat következményeiért a gyártó és forgalmazó nem vállal felelősséget!
HU-MF-000039543No 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.The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in Hungary; available across 1 country total.
Placed on the market in Hungary; per-country availability dates not published.
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.
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 →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 →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 →No certificate specifically references this device's Basic UDI-DI.
5999862705NSL01TQOn the marketElysium orrmosó fecskendő nyuszi fejjel5999862705NSL01TQOn the marketElysium orrmosó só 2,7g - 30 db5999862705SLT01V6On the marketElysium szúnyog- és kullancsriasztó szatén hajgumi - fekete5999862705RPL01UFOn the marketElysium szúnyog- és kullancsriasztó szatén hajgumi - rózsaszín5999862705RPL01UFOn the marketElysium szúnyog- és kullancsriasztó tapasz (0-3 éves korig) - állatos5999862705RPL01UFOn the market