- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Jun 5, 2026
803259587TF02EDCICATRIDINA supositorios 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 Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
080325958718972049(01)08032595871897
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.
Do not use after the expiry date or if the pack is open or damaged. /o utilice el producto después de la fecha de caducidad ni tampoco en caso de que el envase esté abierto o dañado.
Do not use after the expiry date or if the pack is open or damaged. /o utilice el producto después de la fecha de caducidad ni tampoco en caso de que el envase esté abierto o dañado.
Keep out of the reach of children/Mantenga el producto fuera del alcance de los niños.
In case of pregnancy or breastfeeding, since no specific clinical studies have been carried out, consult the doctor before using the device/Si está embarazada o en período de lactancia, dado que no se han realizado estudios clínicos específicos, consulte a su médico antes de utilizar el producto.
Primary placement in Spain; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| SpainPrimary placement | Dec 20, 2022 | Dec 19, 2027 |
IT-MF-000020737The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
OTHER
OTHER
OTHER
Directions for use and warnings: read the instructions for use included in the inside package insert./Instrucciones de uso y advertencias: lea las instrucciones de uso contenidas en el prospecto interno.
OTHER
OTHER
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 →