Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033882233

FEI Number

3033882233

Entity Name

JIANG XI BIG VISION MEDICAL TECHNOLOGY CO.,LTD

City/State/Country

Ganzhou Jiangxi, CN

Establishment Address

Third Floor, Building 2, Ganzhou National High-level Talents Science and Innovation Park, 3 Wudang Mountain, Ganzhou Jiangxi 341008, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Jiang Xi Big Vision Medical Technology Co.,Ltd (Owner Number: 10091843)

Owner / Operator Contact Address

Third Floor, Building 2, Ganzhou National High-level Talents Science and Innovation Park, 3 Wudang Mountain, Ganzhou, CN-JX 341008, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Vision Screener BVS200H, BVS200B, BVS200L, BVS210H, BVS210B, BVS210L Dry Eye Analyzer (BVD6600S) Ophthalmic Laser Diagnosis Device BVF8000S, BVF8000X, BV F8000H, BVF8000M, BVF8000N, BVF8000T, BVF8000L, BVF8000P

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HKO	Refractometer, Ophthalmic	Ophthalmic	Class 1	886.1760	2026-02-11
KYT	Light, Examination, Medical, Battery Powered	General Hospital	Class 1	880.6350	2024-11-07
HLI	Ophthalmoscope, Ac-Powered	Ophthalmic	Class 2	886.1570	2026-02-11

Official Correspondent

hongjun yan

US Agent Details

James Wang Business: LLINS TECHNOLOGY INC Email: fda-rep@llins-tech.com Phone: (720) 2171916

Related Public Records

Same Entity

Jiang Xi Big Vision Medical Technology 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

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3023983572	PLENOPTIKA EUROPE SLU	Madrid Madrid (Province), ES
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3013575858	APPASAMY ASSOCIATES PRIVATE LIMITED ( THIRUBHUVANAI))	Mannadipet Commune Puducherry, IN
1836161	ASPEN SURGICAL PRODUCTS, INC.	Caledonia, MI, US
3045062165	NINGBO FLO OPTICAL TECHNOLOGY DEVELOPMENT CO., LTD.	Ningbo Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033882233. Last updated year: 2026. Please use registration number 3033882233 when referencing this establishment in official correspondence.