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EUDAMED last updated this device on Apr 16, 2024
803395976DT01DT008ZPSWP ONVISION EPIREP 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 Romania. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
05949477000500DT/01/DT/008(01)05949477000500
European Medical Device Nomenclature — the EU product classification assigned to this device.
Q0299OPHTHALMIC DEVICES - OTHER17 warnings recorded — scroll inside the panel to see all entries.
OTHER
Product is for single patient use
Do not use the product if container is damaged or not perfectly closed when you open it for the first time
OTHER
OTHER
Do not use the product after the expiry date indicated on the package;
Primary placement in Romania; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| RomaniaPrimary placement | — | Still on market |
IT-MF-000019321The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
OTHER
OTHER
No interactions with drugs or other eye drops are reported; however, leave at least 15 minutes between administrations of any other eye drops
In case of side effects during use, interrupt the treatment and consult a doctor
OTHER
OTHER
Consult your doctor before you use this product if you are pregnant or breast-feeding
OTHER
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 →803395976DT01DT014ZJOn the marketSUPEROPTIC COMFORT803395976DT01DT014ZJOn the marketSWP ONVISION DEZALERG803395976DT01DT007ZMOn the marketTHERATEARS 5 IN 1 EYECARE DRY OR TIRED OVERNIGHT RESTORE EYE DROPS803395976DT01DT010ZAOn the marketTonimer Allergy Eye Drops803395976DT01DT007ZMOn the marketTONIMER ALLERGY NASAL SPRAYB-ITMF0000193210191375NOn the marketNo certificate specifically references this device's Basic UDI-DI.
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 →