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EUDAMED last updated this device on Apr 16, 2026
B-05055272716901D-KAT R-TYPE (DISPOSABLE PRISM) is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Keeler Ltd. Placed on the EU market in Netherlands. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
050552727169012414-P-2041GB-MF-000009031GB20/965236(01)05055272716901
4 warnings recorded — scroll inside the panel to see all entries.
• Check your Keeler product for signs of transport / storage damage prior to use.
• Always carefully observe the safety rules and other precautions published herein. • Only decontaminate / clean in accordance with a method given in Cleaning (Section 4) of this instruction manual. • Never use the instrument if the ambient temperature, atmospheric pressure, and/or relative humidity are outside the limits specified in this manual. • Should the instrument suffer shocks (for example, should it accidentally fall), follow the check procedure outlined in the 'Servicing and Calibrations' (Section 12); if necessary, return the instrument to the manufacturer for repair. • Use only the listed accessories in conjunction with the instrument; use said accessories only in accordance with the procedures set forth in the instruction manuals.
• Electrical equipment can be affected by electromagnetic interference. If this occurs whilst using this equipment, switch the unit off and reposition.
• For indoor use only (protect from moisture). • This product should not be immersed in fluid.
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.
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.
Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
Primary placement in Netherlands; available across 7 countries total.
| Country | On market since | Until |
|---|---|---|
| NetherlandsPrimary placement | Sep 27, 2018 | Still on market |
| Croatia | Nov 21, 2022 | Still on market |
| Hungary | Mar 27, 2023 | Still on market |
| Poland | Nov 16, 2018 | Still on market |
| Romania | Feb 4, 2020 | Still on market |
| Slovenia | Mar 25, 2026 | Still on market |
| Slovakia | Mar 25, 2026 | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z12120122TONOMETERSPrimary 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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