- Role
- Country
- Date of registration
- Address
FR-MF-000003651CE 690387R-One Robotic Platform is an MDD-legacy 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 Mar 7, 2022
B-RBH01P0000RKPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
D-RBH01P0000RK
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
3 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 in combination with the Mobile Radioprotection Screen and the R-OneTM Consumable Kit. The R-OneTM system is only compatible with 0.014" guidewires, Rapid exchange stent/balloon catheter, 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.
The system must only be connected to a power supply with protective earthing. Do not use the system if cables are worn.
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 6 countries total.
| Country | On market since | Until |
|---|---|---|
| FrancePrimary placement | Sep 6, 2019 | Still on market |
| Poland | Feb 8, 2023 | Still on market |
| Belgium | Feb 20, 2021 | Aug 4, 2022 |
| Germany | Jan 14, 2020 | Mar 29, 2023 |
| Luxembourg | Jun 10, 2021 | Oct 21, 2021 |
| Netherlands | Apr 2, 2021 | Jan 19, 2022 |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
D-RBH01P0000RKBasic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
B-RBH01P0000RKRBH01P0000UDI 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 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.