Winner Medical Co L T D

FDA Filings

This page includes the latest FDA filings for Winner Medical Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Winner Medical Co L T D holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number3007966889
FEI Number3007966889
NameDavid Lennarz
Owner & OperatorWINNER MEDICAL CO., LTD.
Contact AddressWinner Industrial Park No. 660 Bulong Road, Longhua District
Shenzhen CN-44 Guangdong 518109 CN
Official Correspondent
  • Jianquan Li
  • 86-755-28138888-101
US Agent
Importing Logistics Registration
ImporterAMAZON.COM,INC. (NEXA GLOBAL CO INC) C/O FBA -MDWZ
Address410 TERRY AVENUE NORTH
Seattle, WA 98109 UNITED STATES
Importing Logistics Registration
ImporterSavannah Solutions, Inc.
Address22712 Commerce Center Court Suite 160
Sterling, VA 20166, Arcola VA
Email Address20166
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address144 RESEARCH DR
Hampton, VA 23666 US
Establishment Type
  • Manufacture Medical Device
  • Repack or Relabel Medical Device



Registration Number9616433
FEI Number3005076849
NameDavid Lennarz
Owner & OperatorWINNER MEDICAL CO., LTD.
Contact AddressWinner Industrial Park No. 660 Bulong Road, Longhua District
Shenzhen CN-44 Guangdong 518109 CN
Official Correspondent
  • Jianquan Li
  • 86-755-28138888-101
US Agent
Importing Logistics Registration
ImporterWinner Medical Co.,Ltd.
AddressWINNER INDUSTRIAL PARK NO. 660 BULONG RD, LONGHUA DISTRICT
SHENZHEN, 518109 CHINA
Importer TypeRETAILER
SubdivisionCN-44
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address144 RESEARCH DR
Hampton, VA 23666 US
Establishment Type
  • Export Device to the United States But Perform No Other Operation on Device
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device
  • Foreign Private Label Distributor
  • Complaint File Establishment per 21 CFR 820.198



Registration Number3010610940
FEI Number3010610940
NameWinner Medical (Tianmen) Co., Ltd.
Owner & OperatorWINNER MEDICAL CO., LTD.
Contact AddressWinner Industrial Park No. 660 Bulong Road, Longhua District
Shenzhen CN-44 Guangdong 518109 CN
Official Correspondent
  • Jianquan Li
  • 86-755-28138888-101
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressNo. 47, Jianshe South Road, Yuekou Town, 431702 Tianmen, Hubei
Tianmen Hubei, 431702 CN
Establishment TypeManufacture Medical Device



Registration Number3010610950
FEI Number3010610950
NameDavid Lennarz
Owner & OperatorWINNER MEDICAL CO., LTD.
Contact AddressWinner Industrial Park No. 660 Bulong Road, Longhua District
Shenzhen CN-44 Guangdong 518109 CN
Official Correspondent
  • Jianquan Li
  • 86-755-28138888-101
US Agent
Importing Logistics Registration
ImporterAmazon.com, Inc.
Address410 Terry Avenue North
Seattle, WA 98109 UNITED STATES
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address144 RESEARCH DR
Hampton, VA 23666 US
Establishment TypeManufacture Medical Device



Registration Number3008132238
FEI Number3008132238
NameDavid Lennarz
Owner & OperatorWINNER MEDICAL CO., LTD.
Contact AddressWinner Industrial Park No. 660 Bulong Road, Longhua District
Shenzhen CN-44 Guangdong 518109 CN
Official Correspondent
  • Jianquan Li
  • 86-755-28138888-101
US Agent
Importing Logistics Registration
ImporterAmazon.com, Inc.
Address410 Terry Avenue North
Seattle, WA 98109 UNITED STATES
Importing Logistics Registration
ImporterAmazon.com.dedc LLC
Address550 Oak Ridge Road
Hazle Township, PA 18202 UNITED STATES
Importing Logistics Registration
ImporterAmazon.com.kydc, LLC
Address33333 Lyndon B Johnson Fwy
Dallas, TX 75241 UNITED STATES
Importing Logistics Registration
ImporterGolden State FC LLC
Address24300 Nandina Ave
Moreno Valley, CA 92551 UNITED STATES
Importing Logistics Registration
ImporterWinner Medical Co.,Ltd.
AddressWINNER INDUSTRIAL PARK NO. 660 BULONG RD, LONGHUA DISTRICT
SHENZHEN, 518109 CHINA
Importer TypeRETAILER
SubdivisionCN-44
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address144 RESEARCH DR
Hampton, VA 23666 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
Winner Medical Co., Ltd.
winner medical 2020-05-26
Winner Medical Co., Ltd.
winner medical 2020-05-26
Winner Medical Co., Ltd.
PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, Silicone PHMB Foam Dressing With Border2020-05-14
Winner Medical Co., Ltd.
Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing With Border2020-05-14
David Lennarz [WINNER MEDICAL CO., LTD.]
N95 Respirator2020-03-21
David Lennarz [WINNER MEDICAL CO., LTD.]
N95 Respirator2020-03-21
Winner Medical Co., Ltd.
Dimora 2020-02-18
David Lennarz [WINNER MEDICAL CO., LTD.]
Silver Calcium Alginate Dressing2020-01-16
Winner Medical Co., Ltd.
Otc Medication2019-11-20
Winner Medical Co., Ltd.
Otc Medication2019-11-20
David Lennarz [WINNER MEDICAL CO., LTD.]
Minor Procedure Drape with Adhesive Aperture2019-09-01
David Lennarz [WINNER MEDICAL CO., LTD.]
Minor Procedure Drape with Adhesive Aperture2019-09-01
David Lennarz [WINNER MEDICAL CO., LTD.]
Half Drape with Tape2019-09-01
David Lennarz [WINNER MEDICAL CO., LTD.]
Half Drape with Tape2019-09-01
Winner Medical Co., Ltd
Antimicrobial Gauze Sponge Dressing, Antimicrobial Super Sponge Dressing, Antimicrobial Non-woven Sponge Dressing2019-02-14
David Lennarz [WINNER MEDICAL CO., LTD.]
Surgical Tray2018-07-24
David Lennarz [WINNER MEDICAL CO., LTD.]
Surgical Tray2018-07-24
Winner Medical Co., Ltd.
Otc Medication2017-11-27
Winner Medical Co., Ltd.
Otc Medication2017-11-27
Winner Medical Co., Ltd.
Isopropyl Alcohol 70% 4x42017-11-16
Winner Medical Co., Ltd.
Isopropyl Alcohol 70% 3x32017-11-16
David Lennarz [WINNER MEDICAL CO., LTD.]
pillowcase,bed sheet2017-09-17
David Lennarz [WINNER MEDICAL CO., LTD.]
Alcohol Pad2017-07-20
David Lennarz [WINNER MEDICAL CO., LTD.]
Alcohol Pad2017-07-20
David Lennarz [WINNER MEDICAL CO., LTD.]
Suture Removal kit,Tracheostomy Care Kit,Laceration Trays,IV START KIT,SHAVE PREP KIT2015-07-08
David Lennarz [WINNER MEDICAL CO., LTD.]
Suture Removal kit,Tracheostomy Care Kit,Laceration Trays,IV START KIT,SHAVE PREP KIT2015-07-08
David Lennarz [WINNER MEDICAL CO., LTD.]
Dispossable Dressing Tray2015-07-08
David Lennarz [WINNER MEDICAL CO., LTD.]
Dispossable Dressing Tray2015-07-08
David Lennarz [WINNER MEDICAL CO., LTD.]
Super Absorbent Dressing,Silicone Super Absorbent Dressing,Activated Charcoal Super Absorbent Dressing2013-08-06
David Lennarz [WINNER MEDICAL CO., LTD.]
Super Absorbent Dressing,Silicone Super Absorbent Dressing,Activated Charcoal Super Absorbent Dressing2013-08-06
David Lennarz [WINNER MEDICAL CO., LTD.]
Super Absorbent Dressing,Silicone Super Absorbent Dressing,Activated Charcoal Super Absorbent Dressing2013-08-06
David Lennarz [WINNER MEDICAL CO., LTD.]
Super Absorbent Dressing,Silicone Super Absorbent Dressing,Activated Charcoal Super Absorbent Dressing2013-08-06
David Lennarz [WINNER MEDICAL CO., LTD.]
Silicone Foam Bordered Dressing2013-08-06
David Lennarz [WINNER MEDICAL CO., LTD.]
Silicone Foam Bordered Dressing2013-08-06
David Lennarz [WINNER MEDICAL CO., LTD.]
Silicone Foam Bordered Dressing2013-08-06
David Lennarz [WINNER MEDICAL CO., LTD.]
Silicone Foam Bordered Dressing2013-08-06
David Lennarz [WINNER MEDICAL CO., LTD.]
Nonwoven Adhesive wound dressing (Strip)2013-08-06
David Lennarz [WINNER MEDICAL CO., LTD.]
Nonwoven Adhesive wound dressing (Strip)2013-08-06
David Lennarz [WINNER MEDICAL CO., LTD.]
Nonwoven Adhesive wound dressing (Strip)2013-08-06
David Lennarz [WINNER MEDICAL CO., LTD.]
Nonwoven Adhesive wound dressing (Strip)2013-08-06
David Lennarz [WINNER MEDICAL CO., LTD.]
CONFORMANT 2,EXU-DRY,HydraLock SA2013-08-06
David Lennarz [WINNER MEDICAL CO., LTD.]
CONFORMANT 2,EXU-DRY,HydraLock SA2013-08-06
David Lennarz [WINNER MEDICAL CO., LTD.]
CONFORMANT 2,EXU-DRY,HydraLock SA2013-08-06
David Lennarz [WINNER MEDICAL CO., LTD.]
CONFORMANT 2,EXU-DRY,HydraLock SA2013-08-06
David Lennarz [WINNER MEDICAL CO., LTD.]
Alginate dressing,Wound drssing,Finger bangdage2013-08-06
David Lennarz [WINNER MEDICAL CO., LTD.]
Alginate dressing,Wound drssing,Finger bangdage2013-08-06
David Lennarz [WINNER MEDICAL CO., LTD.]
Alginate dressing,Wound drssing,Finger bangdage2013-08-06
David Lennarz [WINNER MEDICAL CO., LTD.]
Alginate dressing,Wound drssing,Finger bangdage2013-08-06
David Lennarz [WINNER MEDICAL CO., LTD.]
Transparent film dressing,2013-01-26
David Lennarz [WINNER MEDICAL CO., LTD.]
Transparent film dressing,2013-01-26
David Lennarz [WINNER MEDICAL CO., LTD.]
Transparent film dressing,2013-01-26
David Lennarz [WINNER MEDICAL CO., LTD.]
Silicone Contact Layer2013-01-26
David Lennarz [WINNER MEDICAL CO., LTD.]
Silicone Contact Layer2013-01-26
David Lennarz [WINNER MEDICAL CO., LTD.]
Silicone Contact Layer2013-01-26
David Lennarz [WINNER MEDICAL CO., LTD.]
Foam Dressing,Silicone Foam Dressing,Hydrocolloid Dressing2013-01-26
David Lennarz [WINNER MEDICAL CO., LTD.]
Foam Dressing,Silicone Foam Dressing,Hydrocolloid Dressing2013-01-26
David Lennarz [WINNER MEDICAL CO., LTD.]
Foam Dressing,Silicone Foam Dressing,Hydrocolloid Dressing2013-01-26
David Lennarz [WINNER MEDICAL CO., LTD.]
Protective Coverall2011-04-20
David Lennarz [WINNER MEDICAL CO., LTD.]
Protective Coverall2011-04-20
Winner Medical (Tianmen) Co., Ltd. [WINNER MEDICAL CO., LTD.]
PC swabs without X-ray thread2010-05-07
Winner Medical (Tianmen) Co., Ltd. [WINNER MEDICAL CO., LTD.]
LARGE STERILE GAUZE PAD2010-05-07
Winner Medical (Tianmen) Co., Ltd. [WINNER MEDICAL CO., LTD.]
DRYNET2010-05-07
Winner Medical (Tianmen) Co., Ltd. [WINNER MEDICAL CO., LTD.]
Conforming stretch gauze2010-05-07
David Lennarz [WINNER MEDICAL CO., LTD.]
PC swabs without X-ray thread2010-05-07
David Lennarz [WINNER MEDICAL CO., LTD.]
PC swabs without X-ray thread2010-05-07
David Lennarz [WINNER MEDICAL CO., LTD.]
PC swabs without X-ray thread2010-05-07
David Lennarz [WINNER MEDICAL CO., LTD.]
LARGE STERILE GAUZE PAD2010-05-07
David Lennarz [WINNER MEDICAL CO., LTD.]
LARGE STERILE GAUZE PAD2010-05-07
David Lennarz [WINNER MEDICAL CO., LTD.]
LARGE STERILE GAUZE PAD2010-05-07
David Lennarz [WINNER MEDICAL CO., LTD.]
DRYNET2010-05-07
David Lennarz [WINNER MEDICAL CO., LTD.]
DRYNET2010-05-07
David Lennarz [WINNER MEDICAL CO., LTD.]
DRYNET2010-05-07
David Lennarz [WINNER MEDICAL CO., LTD.]
Conforming stretch gauze2010-05-07
David Lennarz [WINNER MEDICAL CO., LTD.]
Conforming stretch gauze2010-05-07
David Lennarz [WINNER MEDICAL CO., LTD.]
Conforming stretch gauze2010-05-07
David Lennarz [WINNER MEDICAL CO., LTD.]
Protective Coverall2008-05-20
David Lennarz [WINNER MEDICAL CO., LTD.]
Protective Coverall2008-05-20
David Lennarz [WINNER MEDICAL CO., LTD.]
Isolation gown2008-05-20
David Lennarz [WINNER MEDICAL CO., LTD.]
Isolation gown2008-05-20
David Lennarz [WINNER MEDICAL CO., LTD.]
Medical Face Mask2007-12-21
David Lennarz [WINNER MEDICAL CO., LTD.]
Medical Face Mask2007-12-21
David Lennarz [WINNER MEDICAL CO., LTD.]
TOURNIQUE2003-12-30
Winner Medical (Tianmen) Co., Ltd. [WINNER MEDICAL CO., LTD.]
X-RAY DETECTABLE GAUZE SPONGES2002-05-07
David Lennarz [WINNER MEDICAL CO., LTD.]
X-RAY DETECTABLE GAUZE SPONGES2002-05-07
David Lennarz [WINNER MEDICAL CO., LTD.]
X-RAY DETECTABLE GAUZE SPONGES2002-05-07
Winner Medical (Tianmen) Co., Ltd. [WINNER MEDICAL CO., LTD.]
PC Towel2002-05-07
David Lennarz [WINNER MEDICAL CO., LTD.]
PC Towel2002-05-07
David Lennarz [WINNER MEDICAL CO., LTD.]
PC Towel2002-05-07
David Lennarz [WINNER MEDICAL CO., LTD.]
Cotton Roll, Cotton Ball2002-05-07
David Lennarz [WINNER MEDICAL CO., LTD.]
Cotton Roll, Cotton Ball2002-05-07
David Lennarz [WINNER MEDICAL CO., LTD.]
ABSORBENT TIPPED APPLICATOR2000-01-24
David Lennarz [WINNER MEDICAL CO., LTD.]
ABSORBENT TIPPED APPLICATOR2000-01-24
David Lennarz [WINNER MEDICAL CO., LTD.]
Surgical tape, Cohesive bandage, Elastic adhesive bandage2000-01-24
David Lennarz [WINNER MEDICAL CO., LTD.]
Surgical tape, Cohesive bandage, Elastic adhesive bandage2000-01-24
David Lennarz [WINNER MEDICAL CO., LTD.]
Soft Silicone Tape,Silicone Band Aid2000-01-24
David Lennarz [WINNER MEDICAL CO., LTD.]
Soft Silicone Tape,Silicone Band Aid2000-01-24
David Lennarz [WINNER MEDICAL CO., LTD.]
ATHLETIC TAPE2000-01-24
David Lennarz [WINNER MEDICAL CO., LTD.]
ATHLETIC TAPE2000-01-24
David Lennarz [WINNER MEDICAL CO., LTD.]
ADHESIVE TAPE AND BANDAGE2000-01-24
David Lennarz [WINNER MEDICAL CO., LTD.]
ADHESIVE TAPE AND BANDAGE2000-01-24
David Lennarz [WINNER MEDICAL CO., LTD.]
Eye Pad2000-01-24
David Lennarz [WINNER MEDICAL CO., LTD.]
Eye Pad2000-01-24
David Lennarz [WINNER MEDICAL CO., LTD.]
SURGICALCAPS2000-01-24
David Lennarz [WINNER MEDICAL CO., LTD.]
Shoe Cover2000-01-24
David Lennarz [WINNER MEDICAL CO., LTD.]
SUITS2000-01-24
David Lennarz [WINNER MEDICAL CO., LTD.]
Elastic Bandage, Kinesiology Tape2000-01-24
David Lennarz [WINNER MEDICAL CO., LTD.]
Elastic Bandage, Kinesiology Tape2000-01-24
David Lennarz [WINNER MEDICAL CO., LTD.]
COVER GOWNS2000-01-24
David Lennarz [WINNER MEDICAL CO., LTD.]
Shoe cover2000-01-24

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