- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Jun 8, 2026
803259587TF02EDPROKTIS-M čípky 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.
080325958715832025(01)08032595871583
European Medical Device Nomenclature — the EU product classification assigned to this device.
G05TOPICAL ANORECTAL ADMINISTERED GASTRO-INTESTINAL SYSTEM DEVICES10 warnings recorded — scroll inside the panel to see all entries.
OTHER
OTHER
Directions for use and warnings: read the instructions for use included in the package insert./Způsob užívání a upozornění: přečtěte si příbalový leták obsažený v balení./Návod na použitie a upozornenia: Prečítajte si príbalový leták nachádzajúci sa v balení.
Do not use after the expiry date or if the pack is open or damaged./Nepoužívajte prípravok po uplynutí lehoty použiteľnosti alebo v prípade, ak je obal otvorený alebo poškodený. /Nepoužívejte po datu použitelnosti nebo pokud je balení otevřené nebo poškozené.
Do not use after the expiry date or if the pack is open or damaged./Nepoužívajte prípravok po uplynutí lehoty použiteľnosti alebo v prípade, ak je obal otvorený alebo poškodený. /Nepoužívejte po datu použitelnosti nebo pokud je balení otevřené nebo poškozené.
IT-MF-000020737Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Keep out of the reach of children/Uchovávejte mimo dosah dětí./Uchovávajte mimo dosahu detí.
OTHER
OTHER
OTHER
In case of pregnancy or breastfeeding, since no specific clinical studies have been carried out, consult the doctor before using the device/ Jelikož nebyly provedeny specifické klinické studie, v případě těhotenství nebo kojení se před použitím prostředku poraďte s lékařem./V prípade gravidity alebo dojčenia, keďže neboli vykonané špecifické klinické štúdie, pred používaním pomôcky sa poraďte s lekárom.
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 →Certificate health across this manufacturer's portfolio.
EPT 0477.MDR.23/5102.1ReissuedEPT 0477.MDR.23/5032.1ReissuedEPT 0477.MDR.25/5817IssuedEPT 0477.MDR.25/5818IssuedEPT 0477.MDR.22/5021IssuedEPT 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.
Notified 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 →Notified 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 →Notified 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 →Notified 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 →Notified 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 →