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- Country
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EUDAMED last updated this device on May 20, 2026
8591285PN1KMSOFT,I.-CG pažní návlek,vel.2D s UP HK,tělová is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by MAXIS a.s.. Placed on the EU market in Czechia. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
CZ-MF-000000989(01)08591285109059
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 Czechia; available across 10 countries total.
| Country | On market since | Until |
|---|---|---|
| CzechiaPrimary placement | — | Still on market |
| Germany | — | Still on market |
| EL | — | Still on market |
| France | — | Still on market |
| Hungary | — | Still on market |
| Ireland | — | Still on market |
| Latvia | — | Still on market |
| Poland | — | Still on market |
| Slovenia | — | Still on market |
| Slovakia | — | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
08591285109059Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
8591285PN1KM8591285109059UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
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.
European Medical Device Nomenclature — the EU product classification assigned to this device.
M030405COMPRESSION STOCKINGSPrimary 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 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.No certificate specifically references this device's Basic UDI-DI.
8591285PNB19NOn the marketSOFT,I.-CG pažní návlek,vel.2D s krajkou,tělová8591285PNK1AHOn the marketSOFT,I.-CG pažní návlek,vel.2D s lemem,tělová8591285PNL1ALOn the marketSOFT,I.-CG pažní návlek,vel.2K bez UP,tělová8591285PNB19NOn the marketSOFT,I.-CG pažní návlek,vel.2K s krajkou,tělová8591285PNK1AHOn the marketSOFT,I.-CG pažní návlek,vel.2K s lemem,tělová8591285PNL1ALOn the market