Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011456684

FEI Number

3011456684

Entity Name

JUNHE INDUSTRY AND TRADE CO.,LTD

City/State/Country

Yangjiang Guangdong, CN

Establishment Address

11, 15, 16#, Metal knife cut industrial park, Zhuhai (Yangjiangwanxiang), Yangjiang Guangdong 529932, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

JUNHE INDUSTRY AND TRADE CO.,LTD (Owner Number: 10089879)

Owner / Operator Contact Address

11, 15, 16#, Metal knife cut industrial park, Zhuhai (Yangjiangwanxiang), Yangjiang, CN-GD 529932, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Coating apparatus Nasal Aspirator Skin clearing tool Protector, Hearing (insert) Ear Nose & Throat blindfold Travel mouth set

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LCN	Scraper, Tongue	Dental	Class 1	872.6855	2024-01-17
KAR	Irrigator, Sinus	Ear, Nose, Throat	Class 1	874.4420	2026-02-01
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2024-01-17
EWD	Protector, Hearing (Insert)	Unknown	Class U	N/A	2024-01-22
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2024-01-17
NXZ	Dental Hygiene Kit	Dental	Class 1	872.6855	2024-01-17

Official Correspondent

Qian Liang

US Agent Details

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

Related Public Records

Same Entity

JUNHE INDUSTRY AND TRADE 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
K830425	Maddak, Inc.	TOILET SEAT RAISED	1983-05-09

Similar Registrations

Registration Number	Establishment Name	Location
3003273521	PROFRESH INTERNATIONAL CORP	Philadelphia, PA, US
3007502533	QINGDAO S&R INDUSTRY AND TRADE CO LTD	QINGDAO Shandong, CN
3015337442	JIANGSU HUANYI INDUSTRIAL CO., LTD.	Suqian Jiangsu, CN
3013972866	ROSEMARIE PRODUCTS COMPANY, LLC	Mason, OH, US
3005816808	Shummi Enterprise Co., Ltd.	Taipei, TW

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011456684. Last updated year: 2026. Please use registration number 3011456684 when referencing this establishment in official correspondence.