Manufacturer

Nidek

JapanLegal entities : NIDEK.CO.Ltd.,

Markets : Belgium · Croatia · Cyprus · France · Germany · Netherlands · Norway · Slovenia · Spain · Türkiye · United States

Approvals : EU – class I, IIa, IIb · United States (FDA) – 510(k) : 103 · PMA : 2 · class I, II, III · latest in 2023 · see on the FDA website

Public contracts won : France 23

EU representative : NIDEK SA (France)

12 categories, 15 models including 15 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
Ophtalmology assessments and diagnosis instruments - other	Z12120199	Non-Mydriatic Auto Fundus Camera AFC-1 Non-Mydriatic Auto Fundus Camera AFC-330	IIa MDR	EUDAMED record Report an error
Optometers	Z12120115	REFRACTOR RT-3100 RT-6100,RT-3100,TS-3102 refs REFRACTOR RT-600	I MDR	EUDAMED record Report an error
Phaco-vitrectomy instruments - consumables	Z1212020785	OPHTHALMIC SURGICAL SYSTEM CV-30000 OPHTHALMIC SURGICAL SYSTEM CV-9000	IIb MDR	EUDAMED record Report an error
Laser photocoagulators	Z12120202	Green Laser Photocoagulator GYC-500 YLC-500, GYC-500, MC-5003 refs	IIb MDR	EUDAMED record Report an error
Neodymium surgical laser	Z12011017	OPHTHALMIC YAG LASER SYSTEM YC-200	IIb MDR	EUDAMED record Report an error
Ophtalmology assessments and diagnosis instruments - medical device software	Z12120192	Image Filing Software NAVIS-EX	IIa MDR	EUDAMED record Report an error
Ophthalmological instrument stands	Z12129001	System Table ST-600 ST-600,ST-61002 refs	I MDR	EUDAMED record Report an error
Ophthalmology measurement devices not included in other classes	V030203	PD METER PM-700	I MDR	EUDAMED record Report an error
Ophthalmoscopes	Z12120114	GONIOSCOPE GS-1	IIa MDR	EUDAMED record Report an error
Slit lamps	Z12120108	SLIT LAMP SL-1800 SL-1800, SL-2000, SL-250, SL-4503 refs	I MDR	EUDAMED record Report an error
Tonometers	Z12120122	NON CONTACT TONOMETER NT-1 NT-1/NT-1e2 refs	IIa MDR	EUDAMED record Report an error
Various ophtalmology instruments - medical device software	Z12129092	Fully Assisted Refraction System FARS	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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