Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009620310

FEI Number

3009620310

Entity Name

LINYI 2H HEALTHCARE PRODUCTS CO., LTD

City/State/Country

Linyi Shandong, CN

Establishment Address

NO.9 Kuayue Road,Lizhuang Town,Tancheng county,Linyi Shandong, Linyi Shandong 276016, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Linyi 2H Healthcare Products Co., Ltd (Owner Number: 10040892)

Owner / Operator Contact Address

NO.9 Kuayue Road,Lizhuang Town,Tancheng County,Linyi,Shandong, Linyi, CN-SD 276016, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2020-08-03
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2012-05-31

Official Correspondent

Swift Zhang

US Agent Details

Ang Hu Business: 2H Manufacturing & Distributing Corp Email: angela@2honline.com Phone: (775) 3100098

Related Public Records

Same Entity

Linyi 2H Healthcare Products 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 3009620310. Last updated year: 2026. Please use registration number 3009620310 when referencing this establishment in official correspondence.