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EUDAMED last updated this device on Mar 24, 2026
50552727INDOSCOPES5QAPI 2 LED is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Keeler Ltd. Placed on the EU market in Türkiye. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
050552727113021012-P-7008(01)05055272711302
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z12120114OPHTHALMOSCOPES6 warnings recorded — scroll inside the panel to see all entries.
OTHER
Do not disassemble or modify the battery. There are no serviceable parts inside. Do not dispose of battery in fire, puncture or short circuit. Do not use a battery that is deformed, leaking, corroded or visually damaged. Handle a damaged or leaking battery with care. If you come into contact with electrolyte, wash exposed area with soap and water. If it contacts the eye, seek medical attention immediately.
Check your Keeler product for signs of transport / storage damage prior to use.
Bulbs / LED’s can reach high temperatures in use – allow to cool before handling.
Route power cords safely to eliminate risk of tripping or damage to equipment.
Primary placement in Türkiye; available across 4 countries total.
| Country | On market since | Until |
|---|---|---|
| TürkiyePrimary placement | Mar 26, 2010 | Still on market |
| Spain | Nov 19, 2019 | Still on market |
| France | Sep 22, 2016 | Still on market |
| Ireland | Nov 5, 2019 | Still on market |
GB-MF-000009031The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
This product should not be immersed in fluids. Do not fit mains power adapter into a damaged mains outlet socket. After removal of the bulb / LED do not touch the bulb / LED contacts and the patient simultaneously. The camera should be connected to a PC compliant with Electrical Safety (Medical) EN/IEC 60601-1.
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 certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.No certificate specifically references this device's Basic UDI-DI.
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