Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031168469

FEI Number

3031168469

Entity Name

XUZHOU HENGJIA ELECTRONIC TECHNOLOGY CO., LTD.

City/State/Country

Xuzhou Jiangsu, CN

Establishment Address

No. 13# 2-201, 301, Xiyue Mansion, 28 Chang'an Road, High-techIndustrial Development Zone, Xuzhou Jiangsu 221000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Xuzhou Hengjia Electronic Technology Co., Ltd. (Owner Number: 10090286)

Owner / Operator Contact Address

No. 13# 2-201, 301, Xiyue Mansion, 28 Chang'an Road, High-techIndustrial Development Zone, Xuzhou, CN-JS 221000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Medical 4K camera system, GEV-260R, GEV-260S, GEV-260, GEV-270R, GEV-270S Medical 4K camera system, GEV-270, GEV-280R, GEV-280S, GEV-280, GEV-290R, GEV-290S, GEV-290, GEV-EP3D-4K2 Medical integrated endoscopic camera system, HD-710, HD-720, HD-810, HD-820, HD-910, HD-920, HD-930, HD-960, HD-310 Medical integrated endoscopic camera system, GEV-H350, GEV-H351, GEV-H352, GEV-H360, GEV-H361, GEV-H362, GEV-H363 Medical 4K fluorescent endoscope camera system, GEV-690, GEV-680, GEV-670, GEV-660, GEV-650 Medical integrated endoscopic camera system, GEV-H1100, GEV-H1300, HJ-60, HJ-30 Medical 4K camera system, GEV-610, GEV-620, GEV-630, GEV-640 Medical integrated endoscopic camera system HD-320, HD-330, HD-340, HD-360, HD-370, HD-380, GEV-DL06, GEV-DL07, GEV-DL09 Medical 4K monitor, HD-1710W, HD-1910W, HD-2110W, HD-2410W, HD-2710W, HD-3210W, HD-4310W, HD-5510W

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FWL	Camera, Cine, Endoscopic, Without Audio	General, Plastic Surgery	Class 1	878.4160	2024-03-08
EXZ	Equipment, Photographic, For Physiologic Function Monitor	Gastroenterology, Urology	Class 1	876.1500	2024-03-08

Official Correspondent

Zimin Li

US Agent Details

James St. Wu Business: Humiss Inc. Email: fda-reg@humiss.com Phone: (720) 7595888

Related Public Records

Same Entity

Xuzhou Hengjia Electronic Technology Co., Ltd.

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

View Entity Profile →

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3004361445	AMERICAN MEDICAL ENDOSCOPY	Doral, FL, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031168469. Last updated year: 2026. Please use registration number 3031168469 when referencing this establishment in official correspondence.