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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 2 of 2

Device	Model / Reference	Registries	Class	Status
Image Filing Software NAVIS-EX	19702-0040	EUDAMED	Class IIa	Active
AUTO REFRACTOMETER AR-1s	30613-0040	EUDAMEDFDA UDI	Class IIa	Active
Slit Lamp Sl-1800	B01E014	EUDAMED	Class I	Active
AUTO REF/KERATOMETER ARK-1a	30712-0040	EUDAMEDFDA UDI	Class IIa	Active
Non Contact Tonometer Nt-530	B01E013	EUDAMEDFDA UDI	Class IIa	Active
Slit Lamp Sl-1800	B01E014	EUDAMED	Class I	Active
Auto Lensmeter Lm-1800pd	31019-0140	EUDAMEDFDA UDI	Class I	Active
Non Contact Tonometer Nt-1	NT-1p/NT-1/NT-1e_B01E001	EUDAMED	Class IIa	Active
Chart Projector Cp-9	CP009-0CCF,CP009-0G30,CP009-0G60,CP009-0K30,CP009-0M50,CP009-0T30,CP009-0T3F,CP009-0Z30	EUDAMEDFDA UDI	Class I	Active
Refractor Rt-3100	34090-0S20,34090-0U20,36301-0N41,36301-0ND1,36301-0S41,36301-0SD1,36320-0N40,36320-0ND0,	EUDAMEDFDA UDI	Class I	Active
HANDHELD REF/KERATOMETER HandyRef-K	30721-0A30,30721-0A40,30721-0B30,30721-0B40,30721-0C30,30721-0C40,30721-0D30,30721-0D40	EUDAMEDFDA UDI	Class IIa	Active
AUTO REF/KERATOMETER ARK-1e	30715-0040	EUDAMEDFDA UDI	Class IIa	Active
Refractor Rt-600	33863-0040	EUDAMEDFDA UDI	Class I	Active
NON CONTACT TONOMETER NT-1e	NT-1p/NT-1/NT-1e_B01E001	EUDAMED	Class IIa	Active
Auto Ref/Keratometer Ark-1	30711-0040	EUDAMEDFDA UDI	Class IIa	Active
Auto Refractometer Ar-1	30611-0040	EUDAMEDFDA UDI	Class IIa	Active
OPTICAL BIOMETER AL-Scan	B01E012	EUDAMEDFDA UDI	Class IIa	Active
Ophthalmic Surgical System Cv-9000	Cubeα_B01E001	EUDAMED	Class IIb	Active
Ec-5000 Excimer Laser System	P970053	FDA PMA	Class III	Active

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