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EUDAMED last updated this device on Sep 17, 2025
803395976DT01DT004ZFOPTIDROP KROPLE DO OCZU INTENSYWNE NAWILŻENIE 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 Poland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
07630019302272DT/01/DT/004(01)07630019302272
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.
Do not use the product if the container is damaged or unsealed when first purchased [EN], Nie używać produktu, jeśli opakowanie nosi oznaki uszkodzenia lub nieszczelności [PL].
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Strictly personal use only [EN], Produkt powinien być stosowany przez jedną osobę [PL].
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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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Do not use the product after the expiry date shown on the pack [EN], Nie stosować produktu po upływie terminu ważności podanego na opakowaniu [PL].
Consult your doctor before you use this product if you are pregnant or breast-feeding [EN], W trakcie ciąży lub karmienia piersią, przed użyciem tego produktu skonsultuj się z lekarzem [PL].
If side effects occur during use, stop using the product and consult a doctor [EN], W przypadku wystąpienia działań niepożądanych podczas stosowania należy przerwać kurację i zasięgnąć porady lekarza [PL].
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No interactions with drugs or other eye drops are reported; however, leave at least 15 minutes between administrations of any other eye drops [EN], Nie zgłoszono żadnych interakcji z lekami lub innymi kroplami do oczu, jednakże należy zachować co najmniej 15 minut przerwy pomiędzy podaniem jakichkolwiek innych kropli do oczu [PL].
Primary placement in Poland; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| PolandPrimary placement | — | 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 →No 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 →803395976DT01DT014ZJOn the marketOPTIBEN OJOS SECOS REPAIR803395976DT01DT003ZDOn the marketOPTIBEN OJOS SECOS REPAIR803395976DT01DT003ZDOn the marketOPTIDROP KROPLE DO OCZU ALERGIA I PODRAŻNIENIA803395976DT01DT007ZMOn the marketOPTIDROP Krople do oczu Naturalne łagodzenie803395976DT01DT011ZCOn the marketOPTREX DOBLE ACCIÓN GOTAS OCULARES CALMANTES PICOR DE OJOS803395976DT01DT012ZEOn the market