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EUDAMED last updated this device on Jun 8, 2026
803259587TF02EDPROKTIS-M svečke 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 Slovenia. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
080325958718732039(01)08032595871873
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.
CW999CW999CW999CW010Primary placement in Slovenia; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| SloveniaPrimary 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.
CW032CW007CW135CW275CW999CW999Sterile
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 →