Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014204518

FEI Number

3014204518

Entity Name

JIANGXI HANDASEN INDUSTRY CO., LTD

City/State/Country

Shangrao Jiangxi, CN

Establishment Address

Shaxi Avenue, Zhennan New District, Shaxi Town, Xinzhou District, Shangrao Jiangxi 334008, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

JIANGXI HANDASEN INDUSTRY CO., LTD (Owner Number: 10056633)

Owner / Operator Contact Address

Shaxi Avenue, Zhennan New District, Shaxi Town, Xinzhou District, Shangrao, CN-JX 334008, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Liquid bandage,Cold bandage,Bandage Spray,Plaster Spray Moist Heat Pack POSTURE CORRECTOR Knee brace Lumbar support belt,Back brace,Lumbar brace,Back support Eye shield,eye mask

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NEC	Bandage, Liquid, Skin Protectant	General Hospital	Class 1	880.5090	2021-01-05
IMA	Pack, Heat, Moist	Physical Medicine	Class 1	890.5730	2022-01-07
IPT	Orthosis, Thoracic	Physical Medicine	Class 1	890.3490	2020-01-09
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2020-01-09
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2018-06-03
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2022-01-07

Official Correspondent

Iris He

US Agent Details

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

Related Public Records

Same Entity

JIANGXI HANDASEN INDUSTRY 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 3014204518. Last updated year: 2026. Please use registration number 3014204518 when referencing this establishment in official correspondence.