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EUDAMED last updated this device on Apr 20, 2026
B-FTP9394_3APTUSScontrol 150 ml IT, FR, ES, DE, AT 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 Austria. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
IT-MF-000007965EPT 0477.MDD.21/4366D-FTP9394_3AP
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 Austria; available across 5 countries total.
| Country | On market since | Until |
|---|---|---|
| AustriaPrimary placement | — | Still on market |
| Germany | — | Still on market |
| Spain | — | Still on market |
| France | — | Still on market |
| Italy | — | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
D-FTP9394_3APBasic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
B-FTP9394_3APFTP9394UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
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.
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 →B-FTP068_1KQOn the marketTROSYD Onicodistrofie ITB-FTP068F7On the marketTUSScontrol 10 ml stickpacks IT, FR, ES, DE, ATB-FTP9394_4AROn the marketTussControl Pediatric 150 ml DE805630062FTPR449LOn the marketTussControl Pediatric 150 ml ES805630062FTPR449LOn the marketTussControl Pediatric 150 ml FR805630062FTPR449LOn the marketCertificate 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 →No certificate specifically references this device's Basic UDI-DI.