Instruments for functional explorations and therapeutic interventionsEndoscopic and minimally invasive surgery instrumentsRemote control robotic endoscopic surgery instruments

Robot-assisted endoscopic surgery systems

EMDN code Z12020101

17 manufacturers, 35 models including 34 on the market, 10 countries

On the market in Models on the market only Manufacturer country

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Manufacturers registered in Europe (EUDAMED) 17

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

Manufacturer	Country	Registered models	Class	Contact
Intuitive Surgical FDA EU representative : Intuitive Surgical SAS (France)	United States	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	Website EUDAMED record Report an error
Sterlab	France	ILY7 refs ILY 2001 ILY 2002 ILY 20033 refs ILY 2005 1 other ILY 2024	I, IIa MDR, 93/42	Website contact@sterlab.com EUDAMED record Report an error
Edgemed EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Camera Cable MP10003 refs Camera cable SP10003 refs Camera control unit MSP20003 refs Patient Cart MP1102 Patient Cart SP1102	IIb MDR	EUDAMED record Report an error
CMR Surgical FDA EU representative : Advena Limited (Malta)	United Kingdom (ex Northern Ireland)	Versius 0 Degree Endoscope3 refs Versius Camera Head2 refs	I, IIa MDR	Website EUDAMED record Report an error
Avatera	Germany	avatera Telemanipulator93/42	IIb 93/42	Website regulatory@avateramedical.com EUDAMED record Report an error
Cornerstone Technology (Shenzhen) EU representative : Cornerstone Robotics B.V. (Netherlands)	China	Sentire Surgical System C1000, C1001, C1002, C10033 refs	IIb MDR	Website contact@csrbtx.com EUDAMED record Report an error
Covidien FDA EU representative : Medtronic B.V. (Netherlands)	United States	Hugo™4 refs	IIb MDR	EUDAMED record Report an error
Distalmotion FDA EU representative : Distalmotion Deutschland GmbH (Germany)	Switzerland	Dexter L65 refs	I, IIb MDR	Website info@distalmotion.com EUDAMED record Report an error
Elmed Elektronik Ve Medikal San Tic	Türkiye	Avicenna Roboflex93/42	IIb 93/42	Website EUDAMED record Report an error
Medicaroid EU representative : Medicaroid Europe GmbH (Germany)	Japan	hinotori Surgical Robot System RASM200	IIb MDR	EUDAMED record Report an error
Microport FDA EU representative : MicroPort Medical B.V. (Netherlands)	China	Toumai MT-1000, MT-1000SE,VSS820,MSS810,MVS828,SSS800,12100219,12200010,VSS850,TSP8S0,TSA8C03 refs	IIb MDR	Website EUDAMED record Report an error
Moon Surgical FDA EU representative : Moon Surgical SAS (France)	United States	Maestro System REF101	I MDR	Website info@moonsurgical.com EUDAMED record Report an error
Orthokey FDA	Italy	TRADE NAME ROBIN Robotic Unit	I MDR	quality.assurance@orthokey.eu EUDAMED record Report an error
Robsurgical	Spain	ROB® 00101000	IIb MDR	Website regulatory@robsurgical.com EUDAMED record Report an error
Surgerii EU representative : Surgerii Robotics (Netherlands) B.V. (Netherlands)	China	SHURUI Endoscopic Surgical System SR-ENS-600	IIb MDR	EUDAMED record Report an error
Tuodaomed EU representative : MedNet EC-REP C IIb GmbH (Germany)	China	5100286	IIb MDR	ra@tuodaomed.com EUDAMED record Report an error
Asensus FDA No model still on the market	Italy	Cockpit3 refs (no longer marketed)	IIb 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.

Other manufacturers known in the United States (FDA) 2

Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.

Manufacturer	Country	Brands	FDA clearance
Jossi AG	Switzerland	–	registered
MECAPLAST SA	Switzerland	–	registered

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