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NIDEK CO., LTD.

Japan·JP-MF-000040151

Last updated May 24, 2026

What NIDEK CO., LTD. makes

Nidek Co., Ltd. manufactures ophthalmic diagnostic and surgical devices, including optical coherence tomography systems for retinal imaging, slit lamps for examining the eye’s anterior segment, and non-contact tonometry/pachymetry devices for measuring intraocular pressure and corneal thickness. Their portfolio also includes autorefractometers, keratometers, refractometers, and ophthalmic surgical systems for procedures like cataract surgery, alongside optical projection devices for visual acuity testing.

Nidek’s devices are classified under EU Medical Device Regulations (Class I, IIa, IIb, III) and FDA categories (510(k), PMA), with listings in the EUDAMED registry and the FDA’s premarket submission databases. The company is headquartered in Japan and operates within global regulatory frameworks for medical devices.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: Japan
Address: 34-14, Maehama, Hiroishi-cho, Gamagori, Aichi, Japan
Website: nidek.co.jp
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +81 533 67 8901
PRRC Contact: Nobukazu Suzuki
EUDAMED SRN: JP-MF-000040151
FDA FEI Number: —
DUNS Number: 690635461

Catalogue (69)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
System Table ST-6100	36301-0P41,36301-0T41	EUDAMEDFDA UDI	Class I	Active
Optical Coherence Tomography RS-330	10706-0040, 10706-0F40	EUDAMED	Class IIa	Active
Refractor Rt-6100	36301-0M41,36301-0MD1,36301-0Q41,36301-0QD1,36320-0M40,36320-0MD0,RT015-0U40,RT015-0UD0	EUDAMEDFDA UDI	Class I	Active
System Chart Sc-1600	34607-0040,34607-0080,34607-0P40	EUDAMEDFDA UDI	Class I	Active
NON CONTACT TONO/PACHYMETER NT-1p	NT-1p/NT-1/NT-1e_B01E001	EUDAMED	Class IIa	Active
Slit Lamp Sl-250	B01E006	EUDAMED	Class I	Active
Auto Ref/Kerato/Tono/Pachymeter Tonoref Iii	B01E005	EUDAMED	Class IIa	Active
Auto Refractometer Ar-F	30641-0A40,30641-0B40,30641-0C40,30641-0D40,30641-0E40,30641-0F40	EUDAMEDFDA UDI	Class IIa	Active
Ophthalmic Surgical System Cv-30000	Fortas_B01E007	EUDAMED	Class IIb	Active
Slit Lamp Sl-2000	B01E003	EUDAMEDFDA UDI	Class I	Active
NON CONTACT TONO/PACHYMETER NT-1p	NT-1p/NT-1/NT-1e_B01E001	EUDAMED	Class IIa	Active
Opd-Scan, Models Ark-10000 And Ark-9000	K003299	FDA 510(k)	Class I	Active
Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX	K221320	FDA 510(k)	Class II	Active
Nidek Multicolor Laser Photocoagulator System Mc-500 Connected With The Endophotocoagulation Delivery Unit	K133358	FDA 510(k)	Class II	Active
Yellow Laser Photocoagulator Ylc-500	K170302	FDA 510(k)	Class II	Active
Nidek Multicolor Scan Laser Photocoagulator Mc-500 Vixi	K111493	FDA 510(k)	Class II	Active
Ophthalmoscope F-10	K072259	FDA 510(k)	Class II	Active
Nidek Green Laser Photocoagultor Model Gyc-1000 Connected With The Endophotocoagulation Delivery Unit	K131894	FDA 510(k)	Class II	Active
Ophthalmic Surgical System Cv-9000r	Cubeα_B01E001	EUDAMED	Class IIb	Active
Specular Microscope Cem-530	B01E008	EUDAMEDFDA UDI	Class IIa	Active
Noncontact Tono/Pachymeter Nt-530p	B01E012	EUDAMED	Class IIa	Active
Multicolor Laser Photocoagulator MC-500	B01E003	EUDAMEDFDA UDI	Class IIb	Active
AUTO REFRACTOMETER AR-1a	30612-0040	EUDAMEDFDA UDI	Class IIa	Active
Pd Meter Pm-700	35241-0040	EUDAMEDFDA UDI	Class I	Active
Non Contact Tonometer Nt-1	NT-1p/NT-1/NT-1e_B01E001	EUDAMED	Class IIa	Active
Tabletop Refraction System TS-310	SS001-0040	EUDAMEDFDA UDI	Class I	Active
AUTO REF/KERATOMETER ARK-1s	30713-0040	EUDAMEDFDA UDI	Class IIa	Active
Echoscan Us-4000	B01E012	EUDAMEDFDA UDI	Class IIa	Active
Open-field Refraction System PHANTOM	PH001-0040	EUDAMED	Class IIa	Active
Green Laser Photocoagulator GYC-500	B01E005	EUDAMEDFDA UDI	Class IIb	Active
Fully Assisted Refraction System FARS	RTP15-0A40	EUDAMED	Class IIa	Active
Ophthalmic Yag Laser System Yc-200	B01E006	EUDAMEDFDA UDI	Class IIb	Active
Us-500 Echoscan	B01E012	EUDAMEDFDA UDI	Class IIa	Active
Non-Mydriatic Auto Fundus Camera AFC-330	15411-0E00,15411-00B0	EUDAMEDFDA UDI	Class IIa	Active
HANDHELD REFRACTOMETER HandyRef	30621-0A30,30621-0A40,30621-0B30,30621-0B40,30621-0C30,30621-0C40,30621-0D30,30621-0D40	EUDAMEDFDA UDI	Class IIa	Active
EYE CARE CARD R/W EyeCa-RW2	32196-0500,34085-06A2,34085-06B2	EUDAMED	Class I	Active
Scanning Laser Ophthalmoscope Mirante	SR002-0040,SR002-0S40,	EUDAMEDFDA UDI	Class IIa	Active
Space Saving Chart Ssc-370	33292-0040,33292-0050,33292-0060,33292-00M0,33292-0340,33292-0360,33292-0660,33292-0940,33292-0960,33292-0S60	EUDAMEDFDA UDI	Class I	Active
Auto Lensmeter Lm-1800p	31029-0140	EUDAMEDFDA UDI	Class I	Active
System Table ST-600	36320-0P40	EUDAMEDFDA UDI	Class I	Active
Non Contact Tonometer Nt-510	B01E013	EUDAMEDFDA UDI	Class IIa	Active
Auto Ref/Keratometer Ark-F	30741-0A40,30741-0B40,30741-0C40,30741-0D40,30741-0E40,30741-0F40	EUDAMEDFDA UDI	Class IIa	Active
Auto Lensmeter Lm-7p	31035-0040	EUDAMEDFDA UDI	Class I	Active
Slit Lamp Sl-450	B01E006	EUDAMED	Class I	Active
Microperimeter MP-3	16202-0040,16202-0S40	EUDAMEDFDA 510(k)FDA UDI	Class IIa	Active
Optical Coherence Tomography RS-1	SA002-0040	EUDAMED	Class IIa	Active
Gonioscope Gs-1	B01E007	EUDAMED	Class IIa	Active
REFRACTIVE POWER/CORNEAL ANALYZER OPD-Scan III	B01E009	EUDAMEDFDA UDI	Class IIa	Active
Optical Coherence Tomography RS-3000 Advance	10703-0050, 10703-02B0	EUDAMEDFDA UDI	Class IIa	Active
Auto Lensmeter Lm-7	31035-0N40	EUDAMEDFDA UDI	Class I	Active

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