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Nidek, Inc.

Last updated May 23, 2026

Information

Country: US
Address: —
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FDA FEI Number: —
DUNS Number: —

Catalogue (168)

Page 2 of 4

Device	Model / Reference	Registries	Class	Status
BIO delivery unit (Keeler)	17120-0000	FDA UDI	Class II	Active
Digital Medical Scope	DS-10 Control Unit	FDA UDI	Class I	Active
Sterilized Endophoto Probe(20G/Angled)	11143-6200	FDA UDI	Class II	Active
Image filing software NAVIS-EX	1.12	FDA UDI	Class I	Active
Space Saving Chart	SSC-100	FDA UDI	Class I	Unknown
Digital Medical Scope	DS-20 Control Unit	FDA UDI	Class II	Active
Scan attachable delivery unit (SL-1800)	17452-0000	FDA UDI	Class II	Active
IOL-Station	1.20	FDA UDI	Class I	Active
Sterilized Endophoto Probe(25G/Coaxial)	11143-7500	FDA UDI	Class II	Active
Final Fit™	1.11US	FDA UDI	Class III	Active
AL-Scan Viewer for NAVIS-EX	1.1	FDA UDI	Class II	Active
Scan attachable delivery unit (900BQ)	17468-0000	FDA UDI	Class II	Active
Combination attachable delivery unit (YC-1800)	17148-0000	FDA UDI	Class II	Active
Scan attachable delivery unit (30SL/M)	17465-0000	FDA UDI	Class II	Active
CEM Viewer for NAVIS-EX	1.1	FDA UDI	Class II	Active
Pachymetry probe	14610-0107	FDA UDI	Class II	Active
Scan attachable delivery unit (SL130)	17454-0000	FDA UDI	Class II	Active
Final Fit	1.13	FDA UDI	Class III	Active
IOL-Station	1.21	FDA UDI	Class I	Active
Scan attachable delivery unit (SL130)	17467-0000	FDA UDI	Class II	Active
Sterilized Endophoto Probe(20G/Straight)	11143-6100	FDA UDI	Class II	Active
Digital Medical Scope	DS-10G	FDA UDI	Class I	Active
Sterilized Endophoto Probe(23G/Angled)	11143-6400	FDA UDI	Class II	Active
Attachable delivery unit (SL-1800)	17402-0000	FDA UDI	Class II	Active
A-scan probe	14611-0006	FDA UDI	Class II	Active
Dual delivery unit	17174-0000	FDA UDI	Class II	Active
Slit lamp delivery unit (SL-1800)	17481-0000	FDA UDI	Class II	Active
System Table	ST-5100	FDA UDI	Class I	Active
Scan attachable delivery unit (900BQ)	17457-0000	FDA UDI	Class II	Active
Attachable delivery unit (900BQ)	17108-0000	FDA UDI	Class II	Active
Scan Attachable delivery unit (900BQ)	GEC01	FDA UDI	Class II	Active
Digital Medical Scope	DS-10D	FDA UDI	Class I	Active
Attachable delivery unit (900BQ)	17441-0000	FDA UDI	Class II	Active
Scan slit lamp delivery unit (SL-1800)	17482-0000	FDA UDI	Class II	Active
Auto Ref/Kerato/Tonometer	TONOREF II	FDA UDI	Class II	Active
Scan slit lamp delivery unit (SL-1800)	17428-0000	FDA UDI	Class II	Active
Attachable delivery unit (SL130)	17464-0000	FDA UDI	Class II	Active
Attachable delivery unit (30SL/M)	17431-0000	FDA UDI	Class II	Active
Scan Attachable delivery unit (SL130)	GEA01	FDA UDI	Class II	Active
BIO delivery unit (Heine OMEGA)	17112-0000	FDA UDI	Class II	Active
Data Acquisition Service for NAVIS-EX	1.0	FDA UDI	Class II	Active
Ar-1100 Automatic Refractor	K861065	FDA 510(k)	Class I	Active
Prima Ktp Laser System	K973828	FDA 510(k)	Class II	Active
Nidek Models Ac-2100 & 2200	K913465	FDA 510(k)	Class II	Active
Nidek Prima Model Gyc-1500/2000	K980547	FDA 510(k)	Class II	Active
Anterior Eye-Segment Analysis System	K991284	FDA 510(k)	Class II	Active
Nidek-Binocular Indirect Ophthalmoscope	K843596	FDA 510(k)	Class II	Active
Nidek Cv-4000	K880929	FDA 510(k)	Class II	Active
Non-Contact Tonometer, Model Nt-4000	K031733	FDA 510(k)	Class II	Active
Nidek Us-2000	K903326	FDA 510(k)	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