Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006891803

FEI Number

3006891803

Entity Name

CHANGZHOU HOLYMED PRODUCTS CO., LTD

City/State/Country

CHANGZHOU Jiangsu, CN

Establishment Address

525 CHANGWU ROAD SOUTH, WUJIN DISTRICT, CHANGZHOU Jiangsu 213167, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

CHANGZHOU HOLYMED PRODUCTS CO., LTD (Owner Number: 10024103)

Owner / Operator Contact Address

525 CHANGWU ROAD SOUTH, WUJIN DISTRICT, CHANGZHOU, CN-JS 213167, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

scurb suit Surgical mask Gauze / sponge drape,surgical,gown surgical ice bag MASK, GAS, ANESTHETIC shoe covers, boot covers, arm covers Ortho Shorts Coveralls Stretcher Cover Mastress sheet Baby blanket Infant shirt white surgical gown Isolation Mask Stethoscope Cover Lab Coats, Coveralls Barrier Sleeve Scurb Shirts/Pants wrap,non-sterile Patient cape towel scurb suit protective clothing

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2017-08-23
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2015-05-06
GEC	Brush, Scrub, Operating-Room	General, Plastic Surgery	Class 1	878.4800	2021-05-18
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2021-08-02
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2011-07-11
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2021-06-27
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2014-07-29
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2014-02-07
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2014-02-07
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2017-08-09
KYR	Bag, Ice	General Hospital	Class 1	880.6050	2020-02-10
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2009-05-03
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2008-01-03
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2008-01-03
FME	Gown, Examination	General Hospital	Class 1	880.6265	2010-11-04
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2018-11-30
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-05-16
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2008-01-03
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2012-11-19
LRO	General Surgery Tray	General, Plastic Surgery	Class 2	878.4370	2015-01-26

Official Correspondent

XIAOMING WU

US Agent Details

hui hong Business: ABMED MEDICAL TECHNOLOGY INC Email: info@abmed.us Phone: (303) 8000162

Related Public Records

Same Entity

CHANGZHOU HOLYMED 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
K892118	Paramount Products, Inc.	NON-STERILE MASKS AND CAPS	1989-04-20
K201622	Guangdong Kingfa Sci. & Tech.Co., Ltd.	Medical surgical mask	2020-11-24
K881618	3M Company	ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK	1988-05-09
K914369	Deroyal Industries, Inc.	QUALTEX MAGNETIC INSTRUMENT DRAPE	1991-12-02
K812809	Abco Dealers, Inc.	STERILE ADHERENT DRAPES	1981-11-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0028-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0030-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0031-2025	Windstone Medical Packaging, Inc.	2	Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0095-2021	Alcon Research, LLC	2	Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex Micro Surgical Gloves - Product Usage: used by ophthalmic surgeons in a variety of ophthalmic surgeries.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006891803. Last updated year: 2026. Please use registration number 3006891803 when referencing this establishment in official correspondence.