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EUDAMED last updated this device on Sep 8, 2023
50552727INDOSCOPES5QWIRELESS API 2 KIT A 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 Ireland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
050552727012351204-P-3041(01)05055272701235
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z12120114OPHTHALMOSCOPES13 warnings recorded — scroll inside the panel to see all entries.
• Bulbs / LEDs can reach high temperatures in use – allow to cool before handling.
• Use only Keeler approved batteries, chargers, and power supplies as per the accessories listed in Accessories and Spares section.
• 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.
• Do not use a battery that is deformed, leaking, corroded or visually damaged. Handle a damaged or leaking battery with care. If electrolyte contacts the eye, seek medical attention immediately.
• For indoor use only (protect from moisture). • To prevent condensation from forming, allow instrument to come to room temperature before use. • This product should not be immersed in fluid.
GB-MF-000009031The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
• Keep out of the reach of children.
OTHER
• Interference may occur in the vicinity of equipment marked with this symbol.
• Check your Keeler product for signs of transport / storage damage prior to use.
• 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 35 minutes. Testing was completed with a 20D, 55mm diameter Volk lens. • Do not exceed maximum recommended exposure time. • 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.
• Do not fit mains power adapter into a damaged mains outlet socket. • The mains plug is the means of isolating the device from the mains supply. Ensure both the power switch and mains plug are always accessible. • Before any cleaning of the instrument or the base unit ensure the power lead is disconnected. • When replacing lithium battery pack, turn instrument off and attach new pack. • After removal of the battery do not touch the battery contacts and the patient simultaneously. • After removal of the bulb / LED do not touch the bulb / LED contacts and the patient simultaneously.
• Use only genuine Keeler approved parts and accessories or device safety and performance may be compromised. • Care should be taken when handling halogen bulbs. Halogen bulbs can shatter if scratched or damaged. • No modification to this equipment is allowed. • There are no user serviceable parts inside. Contact authorised service representative for further information. • Ensure battery orientation is correct, or personal injury / damage to equipment may occur. • 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).
• 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.
Primary placement in Ireland; available across 4 countries total.
| Country | On market since | Until |
|---|---|---|
| IrelandPrimary placement | Jul 21, 2008 | Still on market |
| Austria | Aug 16, 2018 | Still on market |
| Netherlands | Jul 25, 2016 | Still on market |
| Türkiye | Mar 26, 2010 | Still on market |
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 →50552727MAINSCCESSORIESDGOn the marketWIRELESS 2 CHARGER MAIN PCB50552727CHARGERSQQOn the marketWIRELESS API (BLUE FILTER)50552727INDOSCOPES5QOn the marketWIRELESS API II IN CARTON50552727INDOSCOPES5QOn the marketWIRELESS API2 & CHARGER IN CARTON50552727INDOSCOPES5QOn the marketWIRELESS CHARGER50552727CHARGERSQQOn the marketNo certificate specifically references this device's Basic UDI-DI.
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.