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Nidek, Inc.

Last updated May 23, 2026

Information

Country: US
Address: —
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Catalogue (168)

Page 1 of 4

Device	Model / Reference	Registries	Class	Status
Sterilized Endophoto Probe(23G/Coaxial)	11143-7300	FDA UDI	Class II	Active
Microperimeter	MP-3 type S	FDA UDI	Class II	Active
Digital Medical Scope	DS-10E	FDA UDI	Class I	Active
Digital Medical Scope	DS-10F	FDA UDI	Class II	Active
Digital Medical Scope	DS-20F	FDA UDI	Class II	Active
Digital Medical Scope	DS-10A	FDA UDI	Class I	Active
Attachable delivery unit (30SL)	17461-0000	FDA UDI	Class II	Active
Endophotocoagulation Delivery Unit	11143-0000(9G4P)	FDA UDI	Class II	Active
Final Fit™	1.12	FDA UDI	Class III	Active
A-scan probe	14610-0006	FDA UDI	Class II	Active
Green Laser Photocoagulator System	GYC-1000	FDA UDI	Class II	Active
Attachable delivery unit (SL130)	GDA01	FDA UDI	Class II	Active
Attachable delivery unit (SL130)	17404-0000	FDA UDI	Class II	Active
Endophotocoagulation Delivery Unit	11143-0000(9M5P)	FDA UDI	Class II	Active
Scan attachable delivery unit (30SL/M)	17451-0000	FDA UDI	Class II	Active
Endophotocoagulation delivery unit	17118-0000	FDA UDI	Class II	Active
Pachymetry probe (45° fixed type)	14610-0108	FDA UDI	Class II	Active
Bio delivery unit (OMEGA 500)	GDD01	FDA UDI	Class II	Active
Attachable delivery unit (900BQ)	17172-0000	FDA UDI	Class II	Active
Scan slit lamp delivery unit (NIDEK SL)	GEB01	FDA UDI	Class II	Active
Slit lamp delivery unit (SL-1800)	17421-0000	FDA UDI	Class II	Active
Optical Biometer	AL-Scan	FDA UDI	Class II	Active
Attachable delivery unit (SL-1800)	17432-0000	FDA UDI	Class II	Active
Image filing software	NAVIS-EX	FDA UDI	Class I	Active
Sterilized Endophoto Probe(23G/Straight)	11143-6300	FDA UDI	Class II	Active
AL-Scan Viewer for NAVIS-EX	1.3	FDA UDI	Class II	Active
A-scan probe	14130-0001	FDA UDI	Class II	Active
Pachymetry probe (45° fixed type)	14130-0006	FDA UDI	Class II	Active
Quest™	EC-5000	FDA UDI	Class III	Active
Slit lamp delivery unit (NIDEK SL)	GDB01	FDA UDI	Class II	Active
Expansion box	17166-6100	FDA UDI	Class II	Active
Attachable delivery unit (SL-1800)	17462-0000	FDA UDI	Class II	Active
CEM Viewer for NAVIS-EX	1.1	FDA UDI	Class II	Active
Attachable delivery unit (SL130)	17434-0000	FDA UDI	Class II	Active
Sterilized Endophoto Probe(25G/Angled)	11143-6600	FDA UDI	Class II	Active
Optical Biometer	AL-Scan	FDA UDI	Class II	Active
Scan attachable delivery unit (SL-1800)	17466-0000	FDA UDI	Class II	Active
Chart Projector	CP-770	FDA UDI	Class I	Active
Slit lamp delivery unit (SL-1800)	17426-0000	FDA UDI	Class II	Active
Ophthalmic Yag Laser System	YC-1800	FDA UDI	Class II	Active
Sterilized Endophoto Probe(27G/Straight)	11143-6700	FDA UDI	Class II	Active
Refractor	RT-5100	FDA UDI	Class I	Active
Digital Medical Scope	DS-10EA	FDA UDI	Class I	Active
Sterilized Endophoto Probe(20G/Coaxial)	11143-7000	FDA UDI	Class II	Active
Ophthalmoscope	F-10	FDA UDI	Class II	Active
Attachable delivery unit (30SL)	17401-0000	FDA UDI	Class II	Active
BIO delivery unit (Heine OMEGA)	17379-0000	FDA UDI	Class II	Active
Sterilized Endophoto Probe(25G/Straight)	11143-6500	FDA UDI	Class II	Active
YAG laser combination delivery unit (YC-1800)	17367-0000	FDA UDI	Class II	Active
YAG laser combination delivery unit (YC-200)	17148-K020	FDA UDI	Class II	Active

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FDA Establishments (2)

Establishments registered with the FDA under this company group, matched by name.

Nidek Co., Ltd. JP
Nidek Sa FR