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EUDAMED last updated this device on Apr 13, 2026
B-FTP040_1J2URGO Żel na afty dla dzieci Gel na afty 8 ml CZ, PL, SK is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Labomar S.p.A.. Placed on the EU market in Czechia. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
D-FTP040_1J2FTP040IT-MF-000007965 EPT 0477.MDD.20/4094D-FTP040_1J2
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
1 warning recorded — scroll inside the panel to see all entries.
CW999Sterile
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 Czechia; available across 3 countries total.
| Country | On market since | Until |
|---|---|---|
| CzechiaPrimary placement | — | Still on market |
| Poland | — | Still on market |
| Slovakia | — | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
V9017ORAL ADMINISTRATION PREPARATIONS NOT INCLUDED IN OTHER CLASSESPrimary 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 →805630062FTPR449LOn the marketURGO Aftas Junior Gel 8 ml ES, PTB-FTP040_2J4On the marketURGO Gel Aphtes Junior 8 ml FRB-FTP040EHOn the marketVIVIN TOSSE COMPLETE 150 mL IT805630062FTPR399TOn the marketVIVIN TOSSE COMPLETE POCKET 14 stickpack 10 mL IT805630062FTPR399TOn the marketVivin Tosse Pediatrico 150 mL IT805630062FTPR389ROn the marketNo certificate specifically references this device's Basic UDI-DI.
Certificate health across this manufacturer's portfolio.
CSQ0026240724SupplementedNotified 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 →