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EUDAMED last updated this device on Mar 17, 2026
5055272745084XR3.6V PRACT / FO DIAGNOSTIC SET 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 Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
050552727199881729-P-1024-500(01)05055272719988
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z12120199OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER13 warnings recorded — scroll inside the panel to see all entries.
• Use only genuine Keeler approved parts and accessories or device safety and performance may be compromised. • Backwards compatibility of the LED module has not been tested. • The product has been designed to function safely when at an ambient temperature between +10°C and +35°C. • Do not use Keeler Retinoscopes or Ophtalmoscopes in ambient temperatures above 35°C. • There are no user serviceable parts inside. Contact authorised service representative for further information. • Ensure device is securely held in docking station to minimise risk of injury or damage to equipment. • Follow guidance on cleaning / routine maintenance to prevent personal injury / damage to equipment. • At product end of life dispose of in accordance with local environmental guidelines (WEEE). • Care should be taken when handling halogen bulbs. Halogen bulbs can shatter if scratched or damaged. • Care should be taken when fitting heads to handles not to trap skin between parts. • Please ensure that the control is in the off position when the examination has been completed. • The product and the ear specula are supplied non-sterile. Do not use on injured tissue. • Use new or sanitised specula to limit the risk of cross-contamination. • If the plastic tip of the Otoscope is not replaced or cleaned properly, infection can spread from one ear to the other. • The disposal of used ear specula must occur in accordance with current medical practices or local regulations regarding the disposal of infectious, biological medical waste.
• Do not fit mains power adapter into a damaged mains outlet socket. • The power switch and mains plug are the means of isolating the device from the mains supply - ensure both the power switch and mains plug are accessible at all times. • To isolate the equipment, disconnect from the mains or switch off at the mains. • Do not position the equipment so that is difficult to press the power switch or remove the mains plug from the wall socket. • Do not touch the terminal contacts of the charging dock or hand unit, or the terminal contacts and the patient simultaneously. • Switch off the electrical supply and disconnect from the mains electrical supply before cleaning and inspection. • After removal of the bulb / LED do not touch the bulb / LED contacts and the patient simultaneously. • After removal of the battery do not touch the battery contacts and the patient simultaneously. • Always ensure that the handle rheostat is turned off before fitting an instrument head or changing a bulb. • When replacing rechargeable cell, turn handle off and insert new cell. Replace bottom cap, and place handle into charging well.
Primary placement in Spain; available across 1 country total.
Placed on the market in Spain; per-country availability dates not published.
GB-MF-000009031The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
• Refraction stand variants or adaptors should only be used in combination with EN/IEC 60601-1 and EN/IEC 60601-1-2 compliant power supplies and devices. • Strong magnetic fields may influence or distort sensitive electronic or mechanical test instruments. Very sensitive devices may even be destroyed. Always keep magnets at a safe distance from such devices.
• Check your Keeler product for signs of transport / storage damage prior to use.
• Interference may occur in the vicinity of equipment marked with this symbol.
• Keep out of the reach of children.
• To prevent condensation from forming, allow instrument to come to room temperature before use. • For indoor use only (protect from moisture). • This product should not be immersed in fluid.
• 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.
• 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.
• Refer to the instructions on page 14 for bulb replacement. • Failure to carry out recommended routine maintenance as per the instructions in this IFU may reduce the operational lifetime of the product. • Use only Keeler approved batteries, chargers, and power supplies as per the accessories listed in section 11.
• Bulbs / LED’s can reach high temperatures in use – allow to cool before handling.
OTHER
• Due to high illumination levels, the Ophthalmoscope and Retinoscope can cause some discomfort in photophobic patients. • Mydriatic agents when used in retinoscopy and ophthalmoscopy can cause temporary symptoms of blurred vision and photophobia. Adverse reactions to mydriatic drops are rare. • The light emitted from this instrument is potentially hazardous. The longer the duration of exposure, the greater the risk of ocular damage. Exposure to light from this instrument when operated at maximum intensity will exceed the safety guideline after 4 hours 20 mins. • While no acute optical radiation hazards have been identified for Ophthalmoscope/ Retinoscope instruments, we recommend keeping the intensity of the light reaching the patient’s retina to the minimum possible for the respective diagnosis. Children, people with aphakia and people suffering from eye conditions are most at risk. An increased risk may also occur if the retina is exposed to the same or a similar device with a visible light source within 24 hours. This applies, in particular, if the retina has been photographed with a flashbulb in advance. • Keeler Ltd shall on request, provide the user with a graph showing the relative spectral output of the instrument.
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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