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EUDAMED last updated this device on Nov 30, 2023
B-08437015992051OpHLINE 3.0% is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by i+Med S.Coop.. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08437015992051PV00006(01)08437015992051
European Medical Device Nomenclature — the EU product classification assigned to this device.
Q02030301OPHTHALMOLOGY, HYALURONIC ACID AND DERIVATIVES9 warnings recorded — scroll inside the panel to see all entries.
SINGLE USE PRODUCT. The reuse of the product may lead to an infection since sterility is compromised after first use.
DO NOT RE-STERILISE, since re-sterilization may affect the physico-chemical properties of the product and compromise its efficacy and security.
The product should not be used if the package is damaged or broken.
The product should not be used after its expiration date.
Primary placement in Spain; available across 3 countries total.
| Country | On market since | Until |
|---|---|---|
| SpainPrimary placement | Sep 4, 2020 | Still on market |
| France | Jun 14, 2023 | Still on market |
| Italy | May 29, 2023 | Still on market |
ES-MF-000008633CE666288KEEP OUT OF THE REACH OF CHILDREN.
Do not use with other products containing quaternary ammonium salts because sodium hyaluronate can precipitate in their presence.
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 →No certificate specifically references this device's Basic UDI-DI.
Certificate health across this manufacturer's portfolio.
2024 CR 0029Issued2026 DR 0071IssuedNotified 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 →Notified 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 →