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EUDAMED last updated this device on Dec 10, 2025
50552727LOUPEFRAMEDB2.5 x 34CM XL ADVANTAGE LOUPE 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.
050552727042672113-P-2000(01)05055272704267
European Medical Device Nomenclature — the EU product classification assigned to this device.
Q0299OPHTHALMIC DEVICES - OTHER6 warnings recorded — scroll inside the panel to see all entries.
• Check your Keeler product for signs of transport / storage damage prior to use.
Re-useable flip lever, protective and 1D caps should not be re-used if visibly contaminated with fluids or blood.
• Use only genuine Keeler approved parts and accessories or device safety and performance may be compromised. • The product has been designed to function safely when at an ambient temperature between +10°C and +35°C. • The Keeler Loupe and Frame restrict the user’s field and depth of view, forcing them to adopt awkward head-neck postures in order to see clearly. • Failure to carry out recommended routine maintenance as per the instructions in this IFU may reduce the operational lifetime of the product. • There are no user serviceable parts in this instrument. Any servicing or repairs should only be carried out by Keeler Ltd. or by suitably trained and authorised distributors. Service manuals will be available to authorised Keeler service centres and Keeler trained service personnel. • Correctly fitted Loupe can help reduce back and neck pain. Spend a few moments ensuring your Loupes are at the optimal angle to suit you. • Following cleaning and/or sterilisation processes inspect the device to ensure all visib
• 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 fluids. • Under no circumstances should the telescopes be autoclaved or immersed in any form of cleaning fluid.
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.
• Keep out of the reach of children.
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.
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 →50552727LOUPEFRAMEDBOn the market2.5 x 34CM LIGHTWEIGHT GALILEAN LOUPE - 90240050552727LOUPEFRAMEDBOn the market2.5 x 34CM XL ADVANTAGE LOUPE50552727LOUPEFRAMEDBOn the market2.5 x 42CM GALILEAN MINI-LOUPE50552727LOUPEFRAMEDBOn the market2.5 x 42CM GALILEAN MINI-LOUPE50552727LOUPEFRAMEDBOn the market2.5 x 42CM LIGHTWEIGHT GALILEAN LOUPE - 90240150552727LOUPEFRAMEDBOn the marketNo 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.