Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015337373

FEI Number

3015337373

Entity Name

CHANGZHOU NEWRISE MEDICAL & HYGIENE PRODUCTS CO., LTD

City/State/Country

Changzhou Jiangsu, CN

Establishment Address

No.39 Chuangye Road, Zhulin Town, Jintan District, Changzhou Jiangsu 213241, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Changzhou Newrise Medical & Hygiene Products Co., Ltd (Owner Number: 10060096)

Owner / Operator Contact Address

No.39 Chuangye Road, Zhulin Town, Jintan District, Changzhou, CN-JS 213241, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Needle pad Washglove Pre-moistened washglove Soaped wipe and washglove Patient transfer sheet Bedpan liner Commode liner Oral swabs Reusable incontinance underpads Exam table rolls Disposable toilet seat cover urinal bag Reusable incontinance underpads Sponge brush Vomit bag Face Shield

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2019-03-29
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2019-03-29
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	2019-03-29
FOB	Bedpan	General Hospital	Class 1	880.6730	2019-03-29
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2019-03-29
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2019-03-29
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2019-03-29
FNP	Urinal	General Hospital	Class 1	880.6730	2019-03-29
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2019-03-29
GEC	Brush, Scrub, Operating-Room	General, Plastic Surgery	Class 1	878.4800	2019-03-29
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	2019-03-29
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-05-08

Official Correspondent

Rachel Zhou

US Agent Details

FANFEI LIU Email: U.S.agent@frosatechnology.com Phone: (626) 8261385

Related Public Records

Same Entity

Changzhou Newrise Medical & Hygiene Products 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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.

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3008886285	Flextronics International Kft	Budapest, HU
3012574325	HAKAMA AG	Baettwil Solothurn, CH
3001397320	ROECHLING MEDICAL ROCHESTER L.P.	Rochester, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015337373. Last updated year: 2026. Please use registration number 3015337373 when referencing this establishment in official correspondence.