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EUDAMED last updated this device on Aug 26, 2025
803395976DT01DT007ZMEUPHRALIA ALLERGIES is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by C.O.C. FARMACEUTICI S.R.L.. Placed on the EU market in Belgium. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08057729510367DT/01/DT/007(01)08057729510367
European Medical Device Nomenclature — the EU product classification assigned to this device.
Q0299OPHTHALMIC DEVICES - OTHER16 warnings recorded — scroll inside the panel to see all entries.
No interactions with drugs or other eye drops are reported; however, leave at least 15 minutes between administrations of any other eye drops [EN], Aucune interaction avec des médicaments ou d’autres gouttes oculaires n’a été signalée ; il convient toutefois d’attendre au moins 15 minutes avant l’administration d’autres gouttes oculaires [FR], Er zijn geen interacties met geneesmiddelen of andere oogdruppels gemeld. Laat echter ten minste 15 minuten tussen de toediening van het product en van andere oogdruppels [NL], Es sind keine Wechselwirkungen mit Arzneimitteln oder anderen Augentropfen bekannt; zwischen der Anwendung anderer Augentropfen sollten jedoch mindestens 15 Minuten liegen [DE].
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IT-MF-000019321The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
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Product is for single patient use [EN], Le produit est destiné à l’usage d’un seul patient [FR], Het product is bestemd voor gebruik bij één patiënt [NL], Das Produkt ist jeweils nur von einem einzigen Patienten zu verwenden [DE].
Do not use the product if container is damaged or not perfectly closed when you open it for the first time [EN], N’utilisez pas le produit si le récipient est endommagé ou n’est pas parfaitement fermé lorsque vous l’ouvrez pour la première fois [FR], Gebruik het product niet als de verpakking beschadigd of niet goed gesloten is wanneer u ze voor de eerste keer opent [NL], Verwenden Sie das Produkt nicht, wenn der Behälter beim ersten Öffnen beschädigt oder nicht richtig verschlossen ist [DE].
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Consult your doctor before you use this product if you are pregnant or breast-feeding [EN], Consultez votre médecin avant d’utiliser ce produit si vous êtes enceinte ou si vous allaitez [FR], Raadpleeg voor het gebruik uw arts als u zwanger bent of borstvoeding geeft [NL], Konsultieren Sie Ihren Arzt, bevor Sie dieses Produkt verwenden, wenn Sie schwanger sind oder stillen [DE].
Do not use the product after the expiry date indicated on the package [EN], N’utilisez pas le produit après la date de péremption indiquée sur l’emballage [FR], Gebruik het product niet meer na de vervaldatum die op de verpakking staat [NL], Verwenden Sie das Produkt nicht mehr nach dem auf der Verpackung angegebenen Verfallsdatum [DE].
Primary placement in Belgium; available across 2 countries total.
| Country | On market since | Until |
|---|---|---|
| BelgiumPrimary placement | — | Still on market |
| Luxembourg | — | Still on market |
Sterile
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 →Certificate health across this manufacturer's portfolio.
091/MDRSupplementedNotified 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.
803395976DT01DT005ZHOn the marketDR.MAX OCNÍ KAPKY803395976DT01DT003ZDOn the marketEUPHRALIA ALERGIA GOTAS OCULARES803395976DT01DT005ZHOn the marketEUPHRALIA ALLERGY GOCCE OCULARI803395976DT01DT007ZMOn the marketEUPHRALIA ALLERGY GOCCE OCULARI MONODOSE803395976DT01DT007ZMOn the marketEUPHRALIA IGIENE BABY GOCCE OCULARI803395976DT01DT005ZHOn the market