Instruments for functional explorations and therapeutic interventionsGeneral and multidisciplinary surgery instrumentsSurgical navigation instruments

Surgical navigation instruments - medical device software

EMDN code Z12011492

9 manufacturers, 22 models including 20 on the market, 6 countries

On the market in Models on the market only Manufacturer country

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Manufacturers registered in Europe (EUDAMED) 9

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
Brainlab FDA	Germany	Alignment Software Cranial, 2.02 refs Cranial EM, 1.193/42 Cranial Navigation System Navigation, 4.093/42 Cranial Navigation System Registration, 3.593/42 Cranial Navigation, 4.12 refs 8 others Cranial/ENT, 3.193/42 ENT EM, 1.293/42 Fluoro 3D, 1.093/42 Instrument Selection, 1.593/42 Registration Software Paired Point, 3.593/42 Registration Software Spine Surface Matching, 1.093/42 Spine & Trauma 3D Navigation, 1.593/42 Spine & Trauma Navigation, 2.03 refs	IIb MDR, 93/42	regulatory.affairs@brainlab.com EUDAMED record Report an error
Therenva FDA	France	EndoNaut (Server) SW v1.x.x EndoNaut v1.2.x	IIb MDR	Website contact@therenva.com EUDAMED record Report an error
Cascination FDA EU representative : CAScination Deutschland GmbH (Germany)	Switzerland	CAS-One IR Software	IIb MDR	Website info@cascination.com EUDAMED record Report an error
Medtronic FDA EU representative : Medtronic B.V. (Netherlands)	United States	S8 Clinical Application Software3 refs	IIb MDR	EUDAMED record Report an error
Move-Up FDA	France	isa™ Planning Software viewup™	IIa MDR	Website EUDAMED record Report an error
R.A.W	Italy	endosight EN000	IIa MDR	Website quality@endo-sight.it EUDAMED record Report an error
X-Nav Technologies FDA EU representative : Emergo Europe B.V. (Netherlands)	United States	X-Guide P008296	IIa MDR	Website regulatory@x-navtech.com EUDAMED record Report an error
Clear Guide Medical FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) No model still on the market	United States	SCENERGY (no longer marketed)	IIa MDR, 93/42	Website info@clearguidemedical.com EUDAMED record Report an error
Perfint Healthcare EU representative : MDSS GmbH (Germany) No model still on the market	India	NAVIOS93/42 (no longer marketed)	IIa 93/42	Website info@perfinthealthcare.com 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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