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EUDAMED last updated this device on Sep 4, 2024
5905868656D40404FAnti-allergic pillowcase Dani is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Onsen Sp. z o.o.. Placed on the EU market in Poland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
590586865668805905868656688PL-MF-000037523(01)59058686566880
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
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 1 country total.
Placed on the market in Poland; per-country availability dates not published.
European Medical Device Nomenclature — the EU product classification assigned to this device.
Y0999PERSONAL CARE AIDS - OTHERPrimary 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.
5905868656D50604UOn the marketAnti-allergic pillowcase Dani5905868656D70805GOn the marketAnti-allergic pillowcase Dani5905868656D40604MOn the marketAnti-decubitus bed cover Airflow Mesh 3D5905123515027XXOn the marketAnti-decubitus bed cover Airflow Mesh 3D5905123515030XLOn the marketAnti-decubitus bed cover Airflow Mesh 3D5905123515031XNOn the marketNo 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.