Manufacturer

Renishaw Mayfield

FranceLegal entities : Renishaw Mayfield SARL

Markets : Belgium · France · United States

Approvals : EU – class I, IIa, IIb · United States (FDA) – 510(k) : 3 · class II · latest in 2018 · see on the FDA website

Public contracts won : France 6

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

Category	EMDN code	Registered models	Class	Contact
Stereotactic neurosurgery instruments - hardware accessories	Z12100680	MRI imaging localizer3 refs neuroinspire PC – Desktop3 refs neurolocate 2D localizer kit3 refs neuromate - Bone insert kit2 refs neuromate - Tool guide OD15 - Long guide (XX = internal diameter)3 refs 5 others neuromate control pedal neuromate Endoscopic tool-holder2 refs neuromate Fischer ZD frame attachment - clamp3 refs Neuromate Head Holder3 refs neuromate Laser tool-holder	I, IIa MDR	EUDAMED record Report an error
Stereotactic neurosurgery instruments - software accessories	Z12100682	neuroinspire SW Atlas module3 refs	IIb MDR	EUDAMED record Report an error
Stereotactic neurosurgery systems	Z12100601	neuromate stereotactic system	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.

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