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DE-MF-000008337170775522ophthafutur octa is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Pharmpur GmbH. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Apr 8, 2022
B-04260260050184Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)04260260050184
6 warnings recorded — scroll inside the panel to see all entries.
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.
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.
Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
Primary placement in Germany; available across 31 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Sep 30, 2018 | Still on market |
| Austria | — | Still on market |
| Belgium | — | Still on market |
| Bulgaria | — | Still on market |
| Cyprus | — | Still on market |
| Czechia | Oct 31, 2021 | Still on market |
| Denmark | May 31, 2021 | Still on market |
| Estonia | — | Still on market |
| EL | Sep 30, 2016 | Still on market |
| Spain | Jun 30, 2021 | Still on market |
| Finland | — | Still on market |
| France | Oct 31, 2018 | Still on market |
| Croatia | Oct 31, 2016 | Still on market |
| Hungary | — | Still on market |
| Ireland | — | Still on market |
| Iceland | — | Still on market |
| Italy | Aug 31, 2016 | Still on market |
| Liechtenstein | — | Still on market |
| Lithuania | — | Still on market |
| Luxembourg | — | Still on market |
| Latvia | — | Still on market |
| Malta | — | Still on market |
| Netherlands | — | Still on market |
| Norway | — | Still on market |
| Poland | — | Still on market |
| Portugal | Jun 30, 2019 | Still on market |
| Romania | Sep 30, 2016 | Still on market |
| Sweden | Jan 31, 2021 | Still on market |
| Slovenia | — | Still on market |
| Slovakia | — | Still on market |
| XI | Jul 31, 2016 | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
04260260050184Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
B-04260260050184500505UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
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.
European Medical Device Nomenclature — the EU product classification assigned to this device.
Q02030205OPHTHALMIC SURGERY, PERFLUOROCARBONS PURE AND COMBINED WITH OTHER SUBSTANCESNo certificate specifically references this device's Basic UDI-DI.
Certificate health across this manufacturer's portfolio.
1000276572Issued1000204102IssuedNotified 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 →