- Role
- Country
- Date of registration
- Address
CZ-MF-000000989No 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.Kovová pomůcka pro navlékání zdravotních kompresivních punčoch - velký 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.
EUDAMED last updated this device on Apr 15, 2026
8591285NAV0249Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)08591285050030
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.
08591285050030Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
8591285NAV02498591285050030UDI 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.
M030499ELASTIC BANDAGES, SUPPORT AND COMPRESSION - OTHERNo certificate specifically references this device's Basic UDI-DI.
8591285ATUM36GOn the marketKovová pomůcka pro navlékání kompresních pažních návleků8591285NAV034BOn the marketKovová pomůcka pro navlékání zdravotních kompresivních punčoch - malý8591285NAV0147On the marketPažní návlek s lemem + rukavice8591285PNSL19SOn the marketRELAX PREMIUM AD vel.L,black magic8591285AD1Q59On the marketRELAX PREMIUM AD vel.L,blue ocean8591285AD1Q59On the market