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EUDAMED last updated this device on Nov 30, 2021
B-06430020484032Ceraderm Intime 100ml is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by Galena Pharma Oy. Placed on the EU market in Finland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
064300204840324032(01)06430020484032
European Medical Device Nomenclature — the EU product classification assigned to this device.
U0803VAGINAL DEVICES IN THE FORM OF SOLUTIONS/CREAMS/OVA/TABLETSPrimary placement in Finland; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| FinlandPrimary placement | Jan 28, 2014 | Still on market |
FI-MF-000000588C-01-1162-775-21Sterile
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-06430020484322On the marketCeraderm Betaglucan 30gB-06430020484315On the marketCeraderm Betaglucan 4 gB-684019REOn the marketFemisan Balance 7x5mlB-06432100056603On the marketFemisan Balance emätingeeli 7x5ml642061571350169BQOn the marketFemisan Cream emätinvoide + aplikaattori 50g642061571725125CSOn the marketCertificate health across this manufacturer's portfolio.
CR-03-1162-806-22SupplementedNotified 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 →