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FR-MF-000003651R-One Robotic Platform is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by ROBOCATH S.A.S. Placed on the EU market in France. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Jul 11, 2025
3770024670RBH01P00004CPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)03770024670127
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
2 warnings recorded — scroll inside the panel to see all entries.
The system should only be used by interventional cardiologists and their staff, who have received specific training for the use of the R-OneTM device. The training provided by Robocath is limited to the use of the system and does not replace the expertise and medical training necessary to perform coronary angioplasty. The movement of the guidewire and/or stent/balloon catheter with the system should not be performed without viewing them using X-rays. The navigation speed of the guidewire and/or stent/balloon catheter should be adapted to the arterial areas traversed. The fast navigation mode should only be used when the guidewire and the stent/balloon catheter are in the guide catheter. The R-OneTM system is not recommended for heavily calcified lesions, ostial lesions, and chronic total occlusions (CTOs). The R-OneTM Robotic Platform is designed to be used exclusively with the Mobile Radioprotection Screen and the R-OneTM Consumable Kit, for Command Unit usable inside the Cathlab. The R-OneTM Robotic Platform is designed to be used exclusively in combination with the R-OneTM Consumable Kit, for command unit usable inside the control room. Mobile Radioprotection Screen can be used as an option. The R-OneTM system is only compatible with: • 0.014" guidewires • Rapid exchange stent/balloon catheters • Y connectors (Super KetchTM by Minvasys, Honor® Hemostasis Valve by Merit Medical). For an optimal use of the system, it is recommended to use a 6 Fr guiding catheter minimum.
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 France; available across 5 countries total.
| Country | On market since | Until |
|---|---|---|
| FrancePrimary placement | Jul 11, 2024 | Still on market |
| Belgium | Jul 11, 2024 | Still on market |
| Germany | Jul 11, 2024 | Still on market |
| Italy | Jul 11, 2024 | Still on market |
| Poland | Jul 11, 2024 | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
03770024670127Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
3770024670RBH01P00004CRBH01P0000UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
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.
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z12059099VARIOUS INSTRUMENTS FOR CARDIOLOGY AND CARDIAC SURGERY -OTHERNo 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.