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EUDAMED last updated this device on Jun 11, 2025
697495736ED002KBOPHTHALMIC SCISSORS(Ring handle type) is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by GAUSH PRECISION LTD. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
0697495736221123-CP004020(01)06974957362211
European Medical Device Nomenclature — the EU product classification assigned to this device.
Q021103OPHTHALMIC SURGERY SCISSORS, SINGLE-USE4 warnings recorded — scroll inside the panel to see all entries.
Do not use on any patients who are sensitive or allergic to metals. Do not use for other purpose than ophthalmic surgery. The user must be fully acquainted with the surgical procedures and techniques. Select the appropriate type of OPHTHALMIC SCISSORS for each surgical purpose.
Avoid using OPHTHALMIC SCISSORS if its packaging is damaged or if there is evidence of any other abnormalities.
CN-MF-000028969The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in Germany; available across 1 country total.
Placed on the market in Germany; per-country availability dates not published.
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.
CN25/00005060IssuedNotified 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 →No certificate specifically references this device's Basic UDI-DI.
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