Winner Medical (Huanggang) Co., Ltd.

Registration Details

Registration Name: Winner Medical (Huanggang) Co., Ltd.
Registration Number: 3007966889
FEI Number: 3007966889
Status: Active
Expiry Year: 2026
Initial Importer: No
Address: Winner Industrial Park, Te1,Chibi Road
City: Huanggang Hubei
Country: CN

Regulatory Submissions

510(k) Number: K895077

Owner / Operator

Firm Name: WINNER MEDICAL CO., LTD.
Operator Number: 9012349
Address: 42nd Floor, Building No.2, Huilong Business Center, Longhua District
City: Shenzhen
State: Guangdong
Postal Code: 518109
Country: CN
Correspondent: Xiaomeng Yang

US Agent

Business Name: REGISTRAR CORP
Contact Name: DAVID LENNARZ
Address: 144 RESEARCH DRIVE, HAMPTON , VIRGINIA , 23666 , UNITED STATES
City: Hampton
State: VA
ZIP: 23666
Country: US
Email: [email protected]
Phone: 757 2240177

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Dressing, Wound, Drug	FRO	Class U	Unknown	No	2021-04-14
Gauze / Sponge,Nonresorbable For External Use	NAB	Class 1	General, Plastic Surgery	No	2010-05-07
Mask, Surgical	FXX	Class 2	General, Plastic Surgery	No	2022-07-15
Elastomer, Silicone, For Scar Management	MDA	Class 1	General, Plastic Surgery	No	2020-08-06
Fiber, Medical, Absorbent	FRL	Class 1	General Hospital	No	2002-05-07
Dressing, Wound, Hydrophilic	NAC	Class 1	General, Plastic Surgery	No	2013-08-06
Dressing, Wound, Occlusive	NAD	Class 1	General, Plastic Surgery	No	2013-01-26
Tape And Bandage, Adhesive	KGX	Class 1	General Hospital	No	2000-01-24
Bandage, Elastic	FQM	Class 1	General Hospital	No	2000-01-24

Proprietary Names

PHMB Foam Dressing PHMB non-adhesive foam dressing PHMB sacral bordered silicone foam dressing with SAF PHMB bordered foam dressing PHMB bordered silicone foam dressing with SAF LARGE STERILE GAUZE PAD PC swabs without X-ray thread Conforming stretch gauze DRYNET Medical Mask Procedure Mask Surgical Face Mask Earloops Face Mask Face Mask Medical Face Mask Medical Face Mask Earloop Silicone Scar Repair Sheet Silicone Scar Gel Silicone Scar Gel Ultra Silicone Ag Foam Dressing Ag Foam Dressing Adhesive Silicone Ag Foam Dressing with Border Ag Foam Dressing Non-adhesive PC Towel Incontinence Underpads Absorbent towel Super Absorbent Dressing Alginate Dressing Nonwoven Adhesive wound dressing (Strip) CMC Gelling Fiber Dressing Wound Dressing ALMORIS Alginate Wound Dressing Activated Charcoal Super Absorbent Dressing Silicone Super Absorbent Dressing transparent dressing Silicone Absorbent Soft Dressing with border HidraWear Superabsorbent Dressing Calcium Alginate Wound Dressing Transparent Dressing Sacrum Silicone Foam Dressing with Border Silicone Contact Layer Transparent Film Dressing Foam Dressing Silicone Foam Dressing Hydrocolloid Dressing Silicone Foam Dressing with Border ALMORIS Silicone Foam Dressing Foam dressing without border Silicone Foam Dressing without Border Dimora HEEL FOAM DRESSING Without Borde HidraWear Foam Dressing Hydrocolloid (Sterile Wound Dressing with Border) Waterproof Foam Dressing Hydrocolloid Roll Procedure mask/Surgical mask/Face mask Medical Earloop Face Mask Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing With Border Surgical tape, Cohesive bandage, Elastic adhesive bandage Soft Silicone Tape,Silicone Band Aid ATHLETIC TAPE Medical Silicone Tape Silicone Adhesive Tape ADHESIVE TAPE AND BANDAGE Silicone tape JOBST Comprifore

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer) Repack or Relabel Medical Device