Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027667933

FEI Number

3027667933

Entity Name

SUZHOU RAISH MEDITECH CO., LTD

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

Floor 2 of Building 8, No. 8 Yangyun Road, Suzhou Industrial Park, Suzhou City, Jiangsu Province, Suzhou Jiangsu 215122, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SUZHOU RAISH MEDITECH CO., LTD (Owner Number: 10095630)

Owner / Operator Contact Address

Floor 2 of Building 8, No. 8 Yangyun Road, Suzhou Industrial Park, Suzhou City, Jiangsu Province, Suzhou, CN-JS 215122, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BINOCULAR INDIRECT OPHTHALMOSCOPE: BIO200, BIO200PLUS, BIO200-D DOUBLE ASPHERIC LENS:DAL20, DAL78, DAL90

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HLI	Ophthalmoscope, Ac-Powered	Ophthalmic	Class 2	886.1570	2026-04-06
HOI	Spectacle, Magnifying	Ophthalmic	Class 1	886.5840	2026-04-06

Official Correspondent

Yongfeng Wu

US Agent Details

Marcela Gonzalez Business: STALLION MEDICAL INC. Email: info@abmed.us Phone: (619) 4286320

Related Public Records

Same Entity

SUZHOU RAISH MEDITECH 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 3027667933. Last updated year: 2026. Please use registration number 3027667933 when referencing this establishment in official correspondence.