Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043152784

FEI Number

3043152784

Entity Name

SHENZHEN SOPHWAY TECHNOLOGY CO., LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

A1301A, Building 1, Meixun Digital Technology Factory, No. 19 Jinxiu Middle Road, Laokeng Community, Longtian Street, Pingshan District,, Shenzhen Guangdong 518122, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shenzhen Sophway Technology Co., Ltd. (Owner Number: 10094859)

Owner / Operator Contact Address

A1301A, Building 1, Meixun Digital Technology Factory, No. 19 Jinxiu Middle Road, Laokeng Community, Longtian Street, Pingshan District,, Shenzhen, CN-GD 518122, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K250204

PMA Number

N/A

All Registered Proprietary Names

Endoscopic LED Light Source (SL-200, SL-200N) Endoscopic Camera System (SV-300, SV-300I, SV-300R, SV-300N)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NTN	Led Light Source	Gastroenterology, Urology	Class 2	876.1500	2025-12-30
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2025-12-30

Official Correspondent

Vivian Liu

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Shenzhen Sophway Technology Co., Ltd.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043152784. Last updated year: 2026. Please use registration number 3043152784 when referencing this establishment in official correspondence.