Manufacturer

Intuitive Surgical

United StatesLegal entities : Intuitive Surgical, Inc.

Markets : Austria · Belgium · Denmark · Finland · France · Germany · Italy · Netherlands · Norway · Romania · Sweden · United States

Approvals : EU – class I, IIa, IIb · United States (FDA) – 510(k) : 199 · class I, II · latest in 2026 · see on the FDA website

Public contracts won : Germany 48 · France 13 · Austria 7 · Denmark 5 · Norway 5 · Belgium 4 · Netherlands 4 · Finland 2 · Sweden 2

EU representative : Intuitive Surgical SAS (France)

Website

12 categories, 25 models including 25 on the market, 1 country

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Robot-assisted endoscopic surgery systems	Z12020101	da Vinci 5 Console – Model: C5000 da Vinci IS5000 Surgical System - Console da Vinci 5 Robot – Model: R5000 da Vinci IS5000 Surgical System - Robot da Vinci 5 Tower – Model: T5000 da Vinci IS5000 Surgical System - Tower da Vinci SP Surgical System - Patient Cart da Vinci SP Surgical System - Surgeon Console 4 others da Vinci SP Surgical System - Vision Cart Model IS4000 da Vinci Xi Surgical System - Patient Cart2 refs Model IS4000 da Vinci Xi Surgical System - Surgeon Console2 refs Model IS4000 da Vinci Xi Surgical System - Vision Cart2 refs	IIb MDR	EUDAMED record Report an error
Video laparoscopes	Z12029016	8 mm Endoscope Plus, 0°3 refs Handheld Camera SP Endoscope, 0°2 refs	I, IIa MDR	EUDAMED record Report an error
Electrosurgical units (ESU) for general use	Z12010902	Da Vinci E-200 Generator3 refs E-100 Electrosurgical Generator2 refs	IIb MDR	EUDAMED record Report an error
Pulmonary endoscopic instruments - other	Z12020899	Controller System Cart	IIa MDR	EUDAMED record Report an error
Various instruments for endoscopy and mini-invasive surgery - consumables	Z12029085	Instrument Sheath SP Endoscope Sheath	IIa MDR	EUDAMED record Report an error
Bronchoscopes	Z12020801	Fully Articulating Catheter2 refs	IIa MDR	EUDAMED record Report an error
Cleaning, disinfection and sterilisation instruments - other	Z12011399	Ion Catheter and Vision Probe Tray	I MDR	EUDAMED record Report an error
Pulmonary endoscopic instruments - consumables	Z12020885	Vision Probe Adapter and Suction Adapter	IIa MDR	EUDAMED record Report an error
Pulmonary endoscopic instruments - medical device software	Z12020892	PlanPoint Software	IIa MDR	EUDAMED record Report an error
Various instruments for endoscopy and mini-invasive surgery - other	Z12029099	Handheld Camera Light Guide	I MDR	EUDAMED record Report an error
Various radiodiagnostic and interventional instruments - hardware accessories	Z11039080	Tomosynthesis Board	I MDR	EUDAMED record Report an error
Video bronchoscopes	Z12020802	Peripheral Vision Probe	IIa MDR	EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

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