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EUDAMED last updated this device on Jun 4, 2026
803259587TF04EHCICATRIDINA mast is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by FARMA-DERMA S.r.l.. Placed on the EU market in Czechia. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
080325958716682016(01)08032595871668
European Medical Device Nomenclature — the EU product classification assigned to this device.
M040499DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER10 warnings recorded — scroll inside the panel to see all entries.
Directions for use and warnings: read the instructions for use included in the package insert./Způsob užívání a upozornění: přečtěte si příbalový leták nacházející se v balení./Návod na použitie a upozornenia: prečítajte si vloženú príbalovú informáciu.
Do not use after the expiry date or if the pack is open or damaged./Nepoužívejte po datu spotřeby nebo pokud je obal otevřený nebo poškozený./Nepoužívajte po dátume vyznačenom na obale, alebo ak je obal otvorený alebo poškodený.
Do not use after the expiry date or if the pack is open or damaged./Nepoužívejte po datu spotřeby nebo pokud je obal otevřený nebo poškozený./Nepoužívajte po dátume vyznačenom na obale, alebo ak je obal otvorený alebo poškodený.
Keep out of the reach of children./Uchovávajte produkt mimo dosahu detí./Uchovávejte mimo dosah dětí.
IT-MF-000020737The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
In case of pregnancy or breastfeeding, since no specific clinical studies have been carried out, consult the doctor before using the device./V prípade tehotenstva a dojčenia, keďže neboli vykonané špecifické klinické štúdie, je pred používaním pomôcky vhodné obrátiť sa na vášho lekára./Jelikož nebyly provedeny specifické klinické studie, v případě těhotenství nebo kojení se před použitím prostředku poraďte s lékařem.
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Primary placement in Czechia; available across 2 countries total.
| Country | On market since | Until |
|---|---|---|
| CzechiaPrimary placement | Dec 20, 2022 | Dec 19, 2027 |
| Slovakia | Dec 20, 2022 | Dec 19, 2027 |
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 →Certificate health across this manufacturer's portfolio.
EPT 0477.MDR.23/5102.1ReissuedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
EPT 0477.MDR.23/5032.1ReissuedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
EPT 0477.MDR.25/5817IssuedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
EPT 0477.MDR.25/5818IssuedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
EPT 0477.MDR.22/5021IssuedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
EPT 0477.MDR.22/5020IssuedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →