Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004496839

FEI Number

3004496839

Entity Name

SHANGHAI HUAYUE PACKAGING PRODUCTS CO., LTD.

City/State/Country

FENGXIAN DISTRICT, SHANGHAI, CN

Establishment Address

NO.228, ZHAIXING RD., ZHELIN TOWN, FENGXIAN DISTRICT, SHANGHAI 201416, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SHANGHAI HUAYUE PACKAGING PRODUCTS CO., LTD. (Owner Number: 9061967)

Owner / Operator Contact Address

NO.228, ZHAIXING RD., ZHELIN TOWN, FENGXIAN DISTRICT, SHANGHAI, CN-NOTA 201416, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

HUAYUE NON-STERILE SPECIMEN MAIL STORAGE CONTAINER Ice Bag Pill Crusher Bag Medicine Cup Impervious Gown HUAYUE PERSONAL HYGIENE KIT Commode Liner Toilet Bowl Liner Pill Crusher Bag Face Mask Protector Cast WIPES DISPENSER EMESIS BAG Urinal Bag Patient Transfer / Repositioning Sheet Body Bags, White

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2006-09-15
KYR	Bag, Ice	General Hospital	Class 1	880.6050	2018-03-07
KYW	Container, Liquid Medication, Graduated	General Hospital	Class 1	880.6430	2023-04-17
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-04-02
NSB	Patient Personal Hygiene Kit	Dental	Class 1	872.6855	2006-09-15
FOB	Bedpan	General Hospital	Class 1	880.6730	2015-12-17
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2006-09-15
OHY	Pill Crusher/Cutter	General Hospital	Class 1	880.6430	2024-12-18
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2020-04-20
KIA	Cover, Cast	General Hospital	Class 1	880.6185	2016-07-29
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2022-12-13
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	2007-07-25
FNP	Urinal	General Hospital	Class 1	880.6730	2021-12-22
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	2008-09-16

Official Correspondent

WANG WEN HUA

US Agent Details

Amy Orrell Business: Mazza Healthcare Email: aorrell@mazzahealthcare.com Phone: (847) 2823444

Related Public Records

Same Entity

SHANGHAI HUAYUE PACKAGING 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 3004496839. Last updated year: 2026. Please use registration number 3004496839 when referencing this establishment in official correspondence.