Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013831261

FEI Number

3013831261

Entity Name

Anhui Shiyin Photoelectric Instrument Co., Ltd.

City/State/Country

Suzhou Anhui, CN

Establishment Address

10 F,100 Shunhe Road, Longcheng Town, Xiao County, Suzhou Anhui 234000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Anhui Shiyin Photoelectric Instrument Co., Ltd. (Owner Number: 10084579)

Owner / Operator Contact Address

10 F,100 Shunhe Road, Longcheng Town, Xiao County, Suzhou, CN-AH 234000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Laryngoscope Rigid Forceps ENT Treatment Unit: SY-ENT0725A, SY-ENT0722A, SY-ENT0720A, SY-ENT0719A, SY-ENT0865A, SY-ENT0855A Accessories. Arthroscopic: SY-JA001, SY-JA002, SY-JA003, SY-ZAR-1 Patient Chait: SY-BRY518 HD VideoRecorder: SY-R100 LED Light Source: SY-SHREK-7712, SY-SHREK-7717, SY-SHREK-7718 LED Light Source: SY-GW700L, SY-GW800L-N, SY-GW1000L-N, SY-GW1200L-N, YOUTAK-GW101, YOUTAK-GW66 Fluorescence LED Cold Light Source: SY-GW1210L Tubing And Tubing/FiIter Fits: SY-PC019, SY-PC020, SY-PC021, SY-PC022, SY-GWG200 Otoscope Scissors Disposable Circumcision Staplers: SY-ST001 Tubing/Tubing With Filter. Insufflation. Laparoscopic: SY-GWQ300, SY-GWQ400, SY-GWQ550 CO2 Insufflator: SY-GWQ550, SY-GWQ400, SY-GWQ300 Irrigation pump: SY-GWGX200, SY-GWG200 Suction and Irrigation pump: SY-GWC200

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2022-03-11
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2022-03-11
ETF	Unit, Examining/Treatment, Ent	Ear, Nose, Throat	Class 1	874.5300	2024-12-05
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2022-03-10
FRK	Chair, Examination And Treatment	General Hospital	Class 1	880.6140	2025-06-24
FEM	Accessories, Photographic, For Endoscope (Exclude Light Sources)	Gastroenterology, Urology	Class 1	876.1500	2022-03-14
EQH	Source, Carrier, Fiberoptic Light	Ear, Nose, Throat	Class 1	874.4350	2022-03-10
NVT	Tubing And Tubing/Filter Fits	Obstetrics/Gynecology	Class 1	884.1700	2022-03-10
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2022-03-11
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2022-03-11
QQS	Stapler, Skin	General Hospital	Class 1	878.4740	2023-04-23
NKC	Tubing/Tubing With Filter, Insufflation, Laparoscopic	Obstetrics/Gynecology	Class 1	884.1730	2022-03-10
NWV	Laparoscopic Accessories, Gynecologic	Obstetrics/Gynecology	Class 1	884.1720	2022-03-11

Official Correspondent

Weilan Sun

US Agent Details

Fanfei Liu Email: U.S.agent@frosatechnology.com Phone: (346) 7358880

Related Public Records

Same Entity

Anhui Shiyin Photoelectric Instrument 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
K851170	The Huxley Instrument Corp.	DISSECTING TWEEZER #283-72PCS. SS 410	1985-04-25
K821248	Conphar, Inc.	ROCHESTER PEAN FORCEPS	1982-05-28
K940152	Hydro-Med Products, Inc.	CAMERA COVER WITH TEAR TIP	1994-10-28
K932506	Rudolf Riester GmbH & Co. KG	RI-SCOPE (S)	1993-10-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0144-2024	Covidien	1	Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
Z-0168-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only
Z-0169-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only
Z-0040-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 3mm Offset (Blue) Catalog Number: 72201713 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0041-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 4mm Offset (Purple Catalog Number: 72201714 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013831261. Last updated year: 2026. Please use registration number 3013831261 when referencing this establishment in official correspondence.