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EUDAMED last updated this device on Oct 17, 2025
805630062FTPR169FIvex 100 mL is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Labomar S.p.A.. Placed on the EU market in Latvia. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08056300621072FTPR16IT-MF-000007965Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →CSQ0026240424(01)08056300621072
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
5 warnings recorded — scroll inside the panel to see all entries.
CW010CW007CW999CW135CW032Sterile
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 Latvia; available across 8 countries total.
| Country | On market since | Until |
|---|---|---|
| LatviaPrimary placement | Still on market | |
| Austria | Still on market | |
| Czechia | Still on market | |
| Estonia | Still on market | |
| Hungary | Still on market | |
| Lithuania | 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 →B-FTP091_3KEOn the marketFTPR16805630062FTPR169FOn the marketFTPR16805630062FTPR169FOn the marketIvex 100 ml EE, LV, LT, CZ, SK, HUB-FTP016ELOn the marketIvex 200 mL805630062FTPR169FOn the marketJalosome Oral Barrier UK, IT, PT, TR, RO, ES, SE, DK, NO, FI, SK, CZ, HUB-FTP082EZOn 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 →