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EUDAMED last updated this device on Nov 7, 2023
803395976DT01DT006ZKON ONE 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 Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08053610310177DT/01/DT/006(01)08053610310177
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.
OTHER
Product is for single patient use
Do not use the product if the aluminum pouch is damaged or if the single dose is not perfectly closed
OTHER
OTHER
In case of side effects during use, interrupt the treatment and consult a doctor
Primary placement in Italy; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | — | Still on market |
IT-MF-000019321The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Do not use the product after the expiry date indicated on the package
OTHER
No interactions with drugs or other eye drops are reported; however, leave at least 15 minutes between administrations of any other eye drops
OTHER
OTHER
OTHER
Consult your doctor before you use this product if you are pregnant or breast-feeding
OTHER
OTHER
OTHER
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.
No certificate specifically references this device's Basic UDI-DI.
803395976DT01DT013ZGOn the marketOCUREP803395976DT01DT007ZMOn the marketON ONE803395976DT01DT006ZKOn the marketOPHTALMIC HYDROFEEL YEUX SECS ET ALLERGIQUES803395976DT01DT007ZMOn the marketOPTAVID BABY S803395976DT01DT005ZHOn the marketOPTIBEN IRRITACIÓN OCULAR+803395976DT01DT001Z9On the market