Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043126966

FEI Number

3043126966

Entity Name

ROBOTRAK TECHNOLOGIES CO., LTD.

City/State/Country

Nanjing Jiangsu, CN

Establishment Address

1F, Building 2, No.6 Qiande Rd, Jiangning District, Nanjing Jiangsu 210000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Robotrak Technologies Co., Ltd. (Owner Number: 10094717)

Owner / Operator Contact Address

1F, Building 2, No.6 Qiande Rd, Jiangning District, Nanjing, CN-JS 210000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HLI	Ophthalmoscope, Ac-Powered	Ophthalmic	Class 2	886.1570	2025-12-18

Official Correspondent

Li Zhang

US Agent Details

Jie Jie Email: jeky.chang@gmail.com Phone: (585) 3199813

Related Public Records

Same Entity

Robotrak Technologies Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K142953	Optomedical Technologies GmbH	OCT-Camera	2015-03-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2018	Optovue, Inc.	2	iVue with Normative Database, Device Listing Number D185549. Product Usage: The iVue (K121739) is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional, and three dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue with Normative Database is a quantitative tool for the comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The iVue with Normative Database is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population.
Z-0010-2018	Optovue, Inc.	2	iVue 500 with iScan, D216606. Product non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional and three-dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue 500 with normative database is a quantitative tool for the comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The iVue 500 with normative database is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population.

Similar Registrations

Registration Number	Establishment Name	Location
1226587	HAI LABORATORIES, INC.	LEXINGTON, MA, US
3003882387	B. ALI IMPEX	SIALKOT, Punjab, PK
3010000450	CRYSTALVUE MEDICAL CORPORATION	Taoyuan Dist.,, TW
1000379039	HEINE OPTOTECHNIK GMBH & CO. KG.	GILCHING Bavaria, DE
3013298431	VEENAK INTERNATIONAL LIMITED	BIRMINGHAM, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043126966. Last updated year: 2026. Please use registration number 3043126966 when referencing this establishment in official correspondence.