- Role
- Country
- Date of registration
- Address
SK-MF-000005837No 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.Kompresy z gázy 10 cm x 20 cm is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by VIDRA a spol. s.r.o.. Placed on the EU market in Slovakia. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Apr 30, 2026
8588006487101040QRPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)08588004670204
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 Slovakia; available across 13 countries total.
| Country | On market since | Until |
|---|---|---|
| SlovakiaPrimary placement | — | Still on market |
| Bulgaria | — | Still on market |
| Czechia | — | Still on market |
| Germany | — | Still on market |
| France | — | Still on market |
| Croatia | — | Still on market |
| Hungary | — | Still on market |
| Lithuania | — | Still on market |
| Latvia | — | Still on market |
| Poland | — | Still on market |
| Portugal | — | Still on market |
| Romania | — | Still on market |
| Slovenia | — | 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.
08588004670204Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
8588006487101040QR101040029UDI 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.
1 packaging level registered — each level carries its own UDI-DI.
08588004670204× 100 unitsBase unit08588006340075× 50 unitsEuropean Medical Device Nomenclature — the EU product classification assigned to this device.
M0201010102COTTON GAUZES, CUT, WITHOUT X-RAY DETECTABLE THREAD, NON-STERILE8588006487101025QVOn the marketGáza v rolke 90 cm x 10 m8588006487101025QVOn the marketKompresy z gázy 10 cm x 10 cm8588006487101040QROn the marketKompresy z gázy 5 cm x 5 cm8588006487101040QROn the marketKompresy z gázy 7,5 cm x 7,5 cm8588006487101040QROn the marketKompresy z netkaného texilu nesterilné 5cm x 5cm858800101040005GNOn the marketNo certificate specifically references this device's Basic UDI-DI.