Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013006775

FEI Number

3013006775

Entity Name

WUHAN DYMEX HEALTHCARE CO., LTD.

City/State/Country

Wuhan Hubei, CN

Establishment Address

Room 1701, Unit 2, Building 5, Jinsegangwan Phase 5,Dongfeng Avenue, Wuhan Hubei 430000, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

WUHAN DYMEX HEALTHCARE CO., LTD. (Owner Number: 10050831)

Owner / Operator Contact Address

Room 1701, Unit 2, Building 5, Jinsegangwan Phase 5,Dongfeng Avenue, Wuhan, CN-HB 430000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Disposable Sterile Radiation Protection Drape GOWN, EXAMINATION Surgical Face Mask Bouffant cap Isolation gown DRESS, SURGICAL Surgical Face Mask( Ear Loops and Tie-on) BEDDING, DISPOSABLE, MEDICAL COVER, SHOE, OPERATING-ROOM Patient gown, Scrub suit Shoe cover surgical mask

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FNW	Pad, Kelly	General, Plastic Surgery	Class 2	878.4370	2024-11-05
FME	Gown, Examination	General Hospital	Class 1	880.6265	2016-03-09
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2019-07-11
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2015-12-31
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2015-12-31
FYE	Dress, Surgical	General, Plastic Surgery	Class 1	878.4040	2016-03-09
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2021-11-17
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2016-03-09
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2016-03-09
FXO	Suit, Surgical	General, Plastic Surgery	Class 1	878.4040	2015-12-31
BWP	Shoe And Shoe Cover, Conductive	General, Plastic Surgery	Class 1	878.4040	2015-12-31
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2016-03-09

Official Correspondent

No official correspondent registered.

US Agent Details

Marco Mu Business: MID-LINK INTERNATIONAL CO., LTD Email: us.agent@mid-link.net Phone: (702) 2095185

Related Public Records

Same Entity

WUHAN DYMEX 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
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

Similar Registrations

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2182979	PMT CORP.	CHANHASSEN, MN, US
3014666579	SHANDONG KANGLI MEDICAL EQUIPMENT TECHNOLOGY CO., LTD.	Zaozhuang Shandong, CN
3008352964	SHANGHAI DOCHEM INDUSTRIES CO., LTD.	SHANGHAI, CN
3005246188	LUCKY IMPEX	Karachi Sindh, PK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013006775. Last updated year: 2026. Please use registration number 3013006775 when referencing this establishment in official correspondence.