Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013398127

FEI Number

3013398127

Entity Name

SIHONG OPHSURIN CO., LTD

City/State/Country

Suqian Jiangsu, CN

Establishment Address

No.22, West Hangzhou Road, Sihong Industrial Park, Sihong County, Suqian Jiangsu 223900, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Sihong Ophsurin Co., Ltd (Owner Number: 10053769)

Owner / Operator Contact Address

No.22, West Hangzhou Road, Sihong Industrial Park, Sihong County, Suqian, CN-JS 223900, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Trabeculotome (Stainless Steel / Titanium); Nucleus Manipulators; Len Manipulator; Epi-peeler; Repositor Marker, ocular (Stainless Steel / Titanium); Phaco Chopper; Diamond Knives Handle; I/A Handpiece; Blade Handle Arruga Globe Retractor; Desmarres Lid Retractor (Stainless Steel / Titanium); Knapp Retractors; Kansas Nucleus Vectis: Fine Thornton Fixation Ring Needle Naqahara Wire Speculum; Barraquer Solid Speculum; Lachrymal Sac Retractor; Titanium Wire Speculum, Wire Speculum: Sprung Speculum. Paediatric; Wire Speculum, Paediatric; Adjustable Speculum; Adjustable Paediatric; Solid Blade Adjustable Speculum; Lindstrom-chu Aspirating Speculum; Wire Speculum with Round Blades; Speculum, V-shaped Wire: Titanium Wire Speculum; Naqahara Titanium Wire Speculum (Stainless Steel / Titanium); Adjustable Speculum, V-shaped Titanium Wire; Titanium Wire Speculum with Round Blades (Stainless Steel / Titanium); Curette (Stainless Steel / Titanium); Iris Hook; Strabismus Hook;Retinal Hook SCISSORS Marker Forceps Caliper (Stainless Steel / Silicone); Sterilizing Trays (Stainless Steel / Titanium); Infusion Handpiece; Infusion Handpiece Double Ends; Aspiration Needle: LASIK Cannula; Capsule Polisher Bulbous Tip; Irrigating-Aspirating Cannula; Pigtail Lacrimal Probe; Aspirating Handpiece Irrigating Vectis; Lacrimal Probe; Lacrimal Probe Double Ends; Punctal Dilator; Posterior Capsule Polisher; Posterior

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HMZ	Trabeculotome	Ophthalmic	Class 1	886.4350	2017-01-10
HND	Spatula, Ophthalmic	Ophthalmic	Class 1	886.4350	2017-01-10
HMR	Marker, Ocular	Ophthalmic	Class 1	886.4570	2017-01-10
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	2017-01-10
HOC	Clip, Iris Retractor	Ophthalmic	Class 1	886.4350	2017-01-10
HNM	Needle, Ophthalmic Suturing	Ophthalmic	Class 1	886.4350	2017-01-10
HNC	Specula, Ophthalmic	Ophthalmic	Class 1	886.4350	2017-01-10
HNZ	Curette, Ophthalmic	Ophthalmic	Class 1	886.4350	2017-01-10
HNQ	Hook, Ophthalmic	Ophthalmic	Class 1	886.4350	2017-01-10
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	2017-01-10
HMQ	Marker, Sclera	Ophthalmic	Class 1	886.4570	2017-01-10
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	2017-01-10
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	2017-01-10
HRK	Table, Instrument, Manual, Ophthalmic	Ophthalmic	Class 1	886.4855	2017-01-10
KYG	Device, Irrigation, Ocular Surgery	Ophthalmic	Class 1	886.4360	2017-01-10

Official Correspondent

Qian Zhang

US Agent Details

Jessie Yao Email: info@medright-tech.com Phone: (718) 2169957

Related Public Records

Same Entity

Sihong Ophsurin 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
K874057	Myocure, Inc.	OPHTHALMIC TIP & BLADE SCALPELS	1987-12-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0026-04	Surgical Specialties Corp	1	Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angled. The product can be sold as an individual unit or in a box of 6 knives.
Z-1922-2024	Alcon Research LLC Aspex Facility	1	20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Z-1923-2024	Alcon Research LLC Aspex Facility	1	ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
Z-1924-2024	Alcon Research LLC Aspex Facility	1	ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
Z-1925-2024	Alcon Research LLC Aspex Facility	1	ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013398127. Last updated year: 2026. Please use registration number 3013398127 when referencing this establishment in official correspondence.