Manufacturer

Topcon

JapanLegal entities : TOPCON CORPORATION

Markets : France · Netherlands · Spain · United States

Approvals : EU – class I, IIa · United States (FDA) – 510(k) : 39 · class I, II · latest in 2026 · see on the FDA website

Public contracts won : France 18 · Spain 7

EU representative : Topcon Europe Medical BV (Netherlands)

Website

10 categories, 33 models including 33 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
Optometers	Z12120115	AUTO KERATO-REFRACTOMETER KA-800PA KR-800PA93/42 AUTO KERATO-REFRACTOMETER KR-14 refs AUTO KERATO-REFRACTOMETER KR-80093/42 AUTO KERATO-REFRACTOMETER KR-800A93/42 AUTO KERATO-REFRACTOMETER KR-800S93/42 4 others AUTO REFRACTOMETER RM-8004 refs REFRACTION SYSTEM Chronos3 refs SightPilot NAVi Controller SNi-1 for REFRACTION SYSTEM Chronos WAVE-FRONT ANALYZER KR-1W2 refs93/42	I MDR, 93/42	EUDAMED record Report an error
Fluoroangiographs	Z12120105	EXTERNAL FIXATION TARGET EF-22 refs NON-MYDRIATIC RETINAL CAMERA TRC-NW40093/42 NON-MYDRIATIC RETINAL CAMERA TRC-NW82 refs93/42 NON-MYDRIATIC RETINAL CAMERA TRC-NW8F93/42 RETINAL CAMERA TRC-50DX2 refs93/42	I, IIa MDR, 93/42	EUDAMED record Report an error
Tonometers	Z12120122	AUTO KERATO-REFRACTO TONOMETER TRK-2P93/42 AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA2 refs COMPUTERIZED TONOMETER CT-14 refs COMPUTERIZED TONOMETER CT-1P93/42 COMPUTERIZED TONOMETER CT-80093/42	IIa MDR, 93/42	EUDAMED record Report an error
Optical consistency tomographs	Z12120121	3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(Type: Maestro2)4 refs 3D OPTICAL COHERENCE TOMOGRAPHY DRI OCT Triton93/42 3D OPTICAL COHERENCE TOMOGRAPHY DRI OCT Triton(plus)93/42 ANTERIOR ATTACHMENT HA-2 for 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1, 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(Type:Maestro2) Optional Accessories for TOPCON 3D Optical Coherent Tomography3 refs	I, IIa MDR, 93/42	EUDAMED record Report an error
Visual functional assessment equipment	Z1212012001	1 DIAL CONTROLLER KB-50S for COMPU VISION CV-5000 Optional Accessory for COMPU VISION CV-50003 refs AUTO CHART PROJECTOR ACP-8(Type: EM)3 refs COMPU VISION CV-50003 refs	I MDR	EUDAMED record Report an error
Operative microscopes	Z12011101	0° ASSISTANT’S MICROSCOPE MS-AM04 for OPERATION MICROSCOPE OMS-800 OPERATION MICROSCOPE OMS-800 (OFFISS)3 refs	I MDR	EUDAMED record Report an error
Slit lamps	Z12120108	BACKGROUND ILLUMINATION BG-53 refs SL-D701 without exciter filter/barrier filter3 refs	I MDR	EUDAMED record Report an error
Corneal confocal microscopes	Z12120110	SPECULAR MICROSCOPE SP-1P2 refs	I, IIa MDR, 93/42	EUDAMED record Report an error
Ophtalmology assessments and diagnosis instruments - medical device software	Z12120192	OPHTHALMIC DATA SYSTEM IMAGEnet 64 refs	I, IIa MDR, 93/42	EUDAMED record Report an error
Ophtalmology assessments and diagnosis instruments - other	Z12120199	NON-MYDRIATIC RETINAL CAMERA NW5003 refs	IIa MDR	EUDAMED record Report an error

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