Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014883395

FEI Number

3014883395

Entity Name

Zhejiang E-WAY Healthcare Co., Ltd.

City/State/Country

Jiaxing Zhejiang, CN

Establishment Address

3081 Cishan Road, Luoxing Street, Jiashan County, Jiaxing Zhejiang 314199, CN

Establishment Type(s)

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

Owner / Operator

Zhejiang E-WAY Healthcare Co., Ltd. (Owner Number: 10062008)

Owner / Operator Contact Address

3081 Cishan Road, Luoxing Street, Jiashan County, Jiaxing, CN-ZJ 314199, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

pH Self Test Liners Medical disposable bedding Scented or scented deodorized medical disposable bed sheets Scented or scented deodorized medical disposable under pad Adult pull up pants Absorbent medical fiber KN95 Face Mask Surgical face masks Dry cotton tissue/wipes

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LNW	Paper, Obstetric Ph	Clinical Chemistry	Class 1	862.1550	2025-07-21
HHD	Pad, Menstrual, Unscented	Obstetrics/Gynecology	Class 1	884.5435	2019-12-11
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2019-12-11
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2019-12-11
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2020-09-03
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2020-03-30
EFN	Cotton, Roll	Dental	Class 1	872.6050	2019-12-11

Official Correspondent

Julie Zhu

US Agent Details

Mark Gordon Email: Mark.W.Gordon@outlook.com Phone: (571) 4072862

Related Public Records

Same Entity

Zhejiang E-WAY Healthcare 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
K823241	Kimberly-Clark Corp.	NEW FREEDOM THIN UNSCENTED MAXI PADS	1982-12-28

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-04	Instrumentation Laboratory Co.	1	Lactate Disposable Membrane Caps Product Number: 0018108400

Similar Registrations

Registration Number	Establishment Name	Location
3024676893	PANGAEA TECHNOLOGIES LLC	The Woodlands, TX, US
3021595883	XIAMEN MK HEALTH CARE PRODUCT CO., LTD.	XIAMEN Fujian, CN
3016609999	GENABIO DIAGNOSTICS INC	Bedford, MA, US
3016621374	Jiangsu Medomics Medical Technology Co., Ltd.	Nanjing Jiangsu, CN
3025041446	2SAN LLC	New York, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014883395. Last updated year: 2026. Please use registration number 3014883395 when referencing this establishment in official correspondence.