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EUDAMED last updated this device on Jul 7, 2026
B-08053306780833CERVINORM PLUS is an MDD-legacy medical device registered in EUDAMED. It is classified as Class I. Manufactured by ADL FARMACEUTICI SRL. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08053306780833ADL-D131(01)08053306780833
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.
Warnings: • Keep out of reach of children. • Do not ingest. • Do not use if the packaging is damaged. • Do not use in case of known hypersensitivity to one or more ingredients. • Do not use in the presence of vaginal lesions or wounds. • Do not use during menstruation. • Do not exceed the recommended dose without medical advice. • Prolonged use may cause sensitization. In such cases, discontinue treatment and consult a doctor to determine appropriate therapy. • Report any adverse effects not mentioned in this leaflet to a doctor or pharmacist. Precautions for use: In pregnant or breastfeeding women, use of the pessaries should be limited to cases of real necessity and under direct medical supervision. In case of an intact hymen, consult your gynecologist before use for specific guidance on application. Single-use device: do not reuse in case of accidental spillage. Reuse may increase the risk of infection.
Primary placement in Italy; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | — | Still on market |
IT-MF-000037063Sterile
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 →B-08053306780789On the marketBUTIRPROST CONF VENDITAB-08053306780772On the marketCOLPOFIX OVULE VAGINALE RO - 10 ovule vaginale 2 gB-08053306780666On the marketCOLPOFIX OVULI VAGINALI IT - conf.campione 2 ovuli da 2 gB-08053306780680On the marketCOLPOFIX OVULI VAGINALI IT - conf.vendita 10 ovuli da 2 gB-08053306780673On the marketNo certificate specifically references this device's Basic UDI-DI.
No 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.