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EUDAMED last updated this device on Jun 17, 2026
B-08053306780758OLINORM GEL VAGINALE is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by ADL FARMACEUTICI SRL. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08053306780758ADL18(01)08053306780758
European Medical Device Nomenclature — the EU product classification assigned to this device.
U0899GYNAECOLOGICAL DEVICES - OTHER1 warning recorded — scroll inside the panel to see all entries.
Non utilizzare in caso di ipersensibilità al prodotto. Evitare il contatto con gli occhi. Nel caso il prodotto venga a contatto con gli occhi, sciacquarli immediatamente con acqua fredda. Tenere fuori dalla portata dei bambini. Non ingerire. Dopo l'uso richiudere accuratamente il tappo e conservare in luogo asciutto al riparo dalla luce diretta ed a una temperatura tra i 5°C e i 30°C. Le cannule sono monouso. Non riutilizzare. Rischio di infezione in caso di riutilizzo. Non utilizzare il prodotto in caso di confezione danneggiata. Lavare le mani prima e dopo l'uso. In caso di lesioni o ferite vaginali chiedere indicazioni al medico prima dell'utilizzo. Utilizzare entro 30 giorni dalla prima apertura.
Primary placement in Italy; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | Nov 24, 2021 | Still on market |
IT-MF-000037063MED-004436-00Sterile
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 →No certificate specifically references this device's Basic UDI-DI.
B-08053306780741On the marketMENORAXON vaginální gelB-08053306780727On the marketOLINOR GEL VAGINALE CONF CAMPIONEB-08053306780765On the marketOLINORM LAVANDA VAGINALEB-08053306780826On the marketOLINORM LAVANDA VAGINALEB-08053306780819On the marketPROEVO UP SUPPOSTE - conf. campione 2 supposte da 2 gB-08053306780659On the marketNo certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.