Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015337442

FEI Number

3015337442

Entity Name

JIANGSU HUANYI INDUSTRIAL CO., LTD.

City/State/Country

Suqian Jiangsu, CN

Establishment Address

Tongzhan road ,Meihua Town ,Sihong county, Suqian Jiangsu 223900, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Jiangsu Huanyi Industrial Co., Ltd. (Owner Number: 10060153)

Owner / Operator Contact Address

Tongzhan road ,Meihua Town ,Sihong county, Suqian, CN-JS 223900, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

TONGUE SCRAPER cold therapy socks Hot & Cold Gel Head Wrap knee brace, ankle wrap, wrist wrap, Freeze Sleeve Therapy Sleeve/ Flat Pak, Headache Relieve Cap, Hot cold pack, ice pack, gel eye mask, cooling mat, hand warmer, herbal heating pad, wine cooler bag, ice bag,

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LCN	Scraper, Tongue	Dental	Class 1	872.6855	2024-12-03
FQL	Stocking, Medical Support (For General Medical Purposes)	General Hospital	Class 1	880.5780	2019-04-04
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2019-04-04

Official Correspondent

Qi Chen

US Agent Details

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

Related Public Records

Same Entity

Jiangsu Huanyi Industrial 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 3015337442. Last updated year: 2026. Please use registration number 3015337442 when referencing this establishment in official correspondence.