Xiamen Compower Medical Tech Co L T D

FDA Filings

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

FDA Registration(s)

• Registration Number: 3008261717
• FEI Number: 3008261717
• Name: Dennis Xu
• Owner & Operator: Xiamen Compower Medical Tech. Co., Ltd.
• Contact Address: Unit 301, No.16, Xianghong Road, Xiang' An Torch Industrial Zone,; Xiamen CN-35 Fujian 361101 CN
• Official Correspondent:
  • Lifen Chen
  • 086-133-06000572-x
• US Agent:
  • Dennis Xu
  • Performance Internatioanl, Corp.
  • 919 8590478
  • ybx99@yahoo.com
• Importing Logistics Registration:
  • Importer: tongue
  • Address: No.16, Xianghong Road, XiangRoad, Xiang'an Torch Industrial ; Xiamen, 361101 CHINA
  • Email Address: dcc@cpmedi.cn
  • Phone: 86 592 5799319
  • FAX: 86 592 5796765
  • Importer Type: Agent
  • Subdivision: CN-35
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 4004 Pepperton Dr ; Raleigh, NC 27606 US
• Establishment Type:
  • Manufacture Medical Device
  • Repack or Relabel Medical Device
  • Export Device to the United States But Perform No Other Operation on Device
  • Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
GUDID 16946430421941 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	MENDYOUMEDICAL	2024-12-04
GUDID 16946430421804 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	MFASCO	2024-12-04
GUDID 16946430421583 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	Lightning X	2024-10-03
GUDID 06946430421579 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	Lightning X	2024-09-26
GUDID 06946430421500 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	ODRESCUE	2024-09-09
GUDID 16946430419900 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	WNLProducts	2024-07-08
GUDID 16946430414844 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	Inkwell Global Marketing	2024-04-03
GUDID 16946430401806 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	Ever Ready First Aid	2024-04-03
GUDID 06946430401618 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	Aquatic Solutions	2024-04-03
GUDID 16946430416107 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	FIRST AID ONLY	2023-11-27
GUDID 16946430415827 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	NAUI	2023-08-30
GUDID 16946430415742 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	Typenex	2023-08-14
GUDID 16946430415735 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	Typenex	2023-08-14
GUDID 16946430415711 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	Typenex	2023-08-14
GUDID 16946430415704 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	Typenex	2023-08-14
GUDID 16946430415698 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	Typenex	2023-08-14
GUDID 16946430415681 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	Typenex	2023-08-14
GUDID 06946430415721 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	Typenex	2023-08-14
GUDID 06946430415332 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	Compower	2023-07-28
GUDID 16946430415391 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	Spiracle Technology	2023-06-23
GUDID 16946430415322 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	Compower	2023-06-23
GUDID 06946430415387 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	Compower	2023-06-23
GUDID 06946430415370 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	Compower	2023-06-23
GUDID 06946430415363 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	Compower	2023-06-23
GUDID 06946430415356 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	Compower	2023-06-23
GUDID 06946430415349 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	Compower	2023-06-23
GUDID 06946430415202 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	Compower	2023-05-29
GUDID 16946430415216 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	Compower	2023-05-26
GUDID 16946430415186 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	Compower	2023-05-08
GUDID 16946430414370 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	EMI	2022-11-23
GUDID 16946430414363 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	EMI	2022-11-23
GUDID 16946430414356 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	KEMP USA	2022-11-23
GUDID 16946430414059 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	compower	2022-09-16
GUDID 16946430413663 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	Lightning X Products, Inc	2022-05-09
GUDID 16946430413656 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	EMI	2022-03-28
GUDID 16946430413649 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	EMI	2022-03-28
GUDID 16946430413632 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	WNL Product	2022-03-11
GUDID 16946430413625 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	WNL Product	2022-03-11
GUDID 16946430413342 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	compower	2022-03-01
GUDID 16946430413335 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	compower	2022-03-01
GUDID 16946430413328 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	compower	2022-02-28
GUDID 16946430413243 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	WNL Product	2022-01-24
GUDID 06946430413253 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	WNL Product	2022-01-24
GUDID 06946430412942 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	Compower	2021-11-01
GUDID 16946430410877 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	Compower	2021-09-23
GUDID 16946430410860 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	Compower	2021-09-23
GUDID 16946430410853 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	Compower	2021-09-23
GUDID 16946430410846 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	Compower	2021-09-23
GUDID 16946430410839 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	Compower	2021-09-23
GUDID 06946430410887 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	Compower	2021-09-23
PMN K210288 Xiamen Compower Medical Tech. Co., Ltd.	Disposable Manual Resuscitator	2021-08-26
GUDID 16946430403770 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	Ever Ready	2021-03-16
GUDID 16946430403763 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	Ever ONE	2021-03-16
GUDID 16946430410631 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	WNL Product	2021-01-04
GUDID 16946430410624 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	WNL products	2021-01-04
GUDID 16946430410495 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	MY MEDIC	2020-11-09
GUDID 16946430410488 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	WNL Product	2020-11-02
GUDID 16946430410471 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	WNL	2020-10-26
GUDID 16946430410419 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	Ever Ready First Aid	2020-08-18
GUDID 16946430410402 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	Ever One	2020-08-18
GUDID 16946430410372 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	WNL Product	2020-08-10
GUDID 16946430410396 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	WNL product	2020-08-06
GUDID 16946430410389 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	WNL Product	2020-08-04
GUDID 16946430410365 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	WNL Product	2020-07-23
GUDID 16946430410327 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	American Red Cross	2020-04-08
GUDID 16946430410310 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	WNL Product	2020-04-08
GUDID 16946430410303 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	American Red Cross	2020-04-08
GUDID 16946430410297 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	WNL Product	2020-04-07
GUDID 16946430410280 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	WNL product	2020-03-30
LYU Dennis Xu [Xiamen Compower Medical Tech. Co., Ltd.]	FACE SHIELD, PROTECTIVE, ISOLATION MASK	2020-03-21
HOY Dennis Xu [Xiamen Compower Medical Tech. Co., Ltd.]	EYE, PROTECTIVE, EYEWEAR, GOGGLES	2020-03-21
GUDID 16946430410273 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	American Red Cross	2020-02-13
GUDID 06946430410269 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	WNL product	2020-02-13
GUDID 16946430401813 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	Ever Ready First Aid	2019-07-23
GUDID 26946430400981 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	MCR	2019-01-31
GUDID 26946430400974 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	MCR	2019-01-31
GUDID 26946430400967 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	MCR	2019-01-31
GUDID 26946430400950 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	MCR	2019-01-31
GUDID 16946430401301 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	Zulco International Inc	2019-01-31
GUDID 16946430401295 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	Zulco International Inc	2019-01-31
GUDID 26946430401285 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	Ever One	2018-12-21
GUDID 26946430401278 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	Ever One	2018-12-21
GUDID 26946430401261 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	Ever One	2018-12-21
GUDID 26946430401254 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	Ever One	2018-12-21
GUDID 26946430401247 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	Ever One	2018-12-21
GUDID 26946430401230 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	Ever One	2018-12-21
GUDID 26946430401100 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	EVER READY FIRST AID	2018-12-21
GUDID 26946430401094 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	EVER READY FIRST AID	2018-12-21
GUDID 26946430401087 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	EVER READY FIRST AID	2018-12-21
GUDID 26946430401070 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	EVER READY FIRST AID	2018-12-21
GUDID 26946430401063 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	EVER READY FIRST AID	2018-12-21
GUDID 26946430401056 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	EVER READY FIRST AID	2018-12-21
GUDID 16946430401042 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	compower	2018-12-21
GUDID 16946430401035 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	compower	2018-12-21
GUDID 16946430401011 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	compower	2018-12-21
GUDID 16946430401004 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	EVER READY FIRST AID	2018-12-21
GUDID 16946430400991 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	EVER READY FIRST AID	2018-12-21
GUDID 06946430401021 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	compower	2018-12-21
GUDID 06946430400901 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	Dixie EMS Supply	2018-12-21
GUDID 16946430401226 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	Ever Ready First Aid	2018-11-26
GUDID 16946430401219 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	Ever Ready First Aid	2018-11-26
GUDID 16946430401165 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	Ever Ready First Aid	2018-11-26
GUDID 06946430401113 XIAMEN COMPOWER MEDICAL TECH. CO., LTD	worldpoint	2018-11-23
PXC Dennis Xu [Xiamen Compower Medical Tech. Co., Ltd.]	Personal Protection Kit, glove	2017-12-17
OEV Dennis Xu [Xiamen Compower Medical Tech. Co., Ltd.]	Cardiopulmonary Resuscitation Aid Kit, with CPR Mask	2017-12-17
LKB Dennis Xu [Xiamen Compower Medical Tech. Co., Ltd.]	Pad, alcohol, device disinfectant, alcohol pad	2017-12-17
PMN K171961 | CBP Dennis Xu [Xiamen Compower Medical Tech. Co., Ltd.]	Non-Rebreathing Valve (18.5mm)	2017-12-06
PMN K171961 | CBP Dennis Xu [Xiamen Compower Medical Tech. Co., Ltd.]	Non-Rebreathing Valve (15mmOD)	2017-12-06
PMN K171961 | CBP Dennis Xu [Xiamen Compower Medical Tech. Co., Ltd.]	Infant CPR Mask with Oxygen Port	2017-12-06
PMN K171961 | CBP Dennis Xu [Xiamen Compower Medical Tech. Co., Ltd.]	CPR Mask without Oxygen Port	2017-12-06
PMN K171961 | CBP Dennis Xu [Xiamen Compower Medical Tech. Co., Ltd.]	CPR Mask with Oxygen Port	2017-12-06
PMN K171961 Xiamen Compower Medical Tech. Co. Ltd.	Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm)	2017-11-17
FMA Dennis Xu [Xiamen Compower Medical Tech. Co., Ltd.]	tongue	2015-07-28
ECB Dennis Xu [Xiamen Compower Medical Tech. Co., Ltd.]	Syringe	2015-03-16
BTK Dennis Xu [Xiamen Compower Medical Tech. Co., Ltd.]	Headgear	2013-05-28
BYG Dennis Xu [Xiamen Compower Medical Tech. Co., Ltd.]	OXYGEN MASK	2013-01-08
BYF Dennis Xu [Xiamen Compower Medical Tech. Co., Ltd.]	Venturi Mask	2013-01-08
CAE Dennis Xu [Xiamen Compower Medical Tech. Co., Ltd.]	Oropharyngeal Airway	2012-04-10
BXJ Dennis Xu [Xiamen Compower Medical Tech. Co., Ltd.]	Nose Clip	2012-04-10
KBN Dennis Xu [Xiamen Compower Medical Tech. Co., Ltd.]	Mouth Opener	2012-04-08
IDZ Dennis Xu [Xiamen Compower Medical Tech. Co., Ltd.]	Tissue Cassettes	2011-08-15
KGB Dennis Xu [Xiamen Compower Medical Tech. Co., Ltd.]	Rescue mask	2010-03-01
KGB Dennis Xu [Xiamen Compower Medical Tech. Co., Ltd.]	Non-Rebreathing mask	2010-03-01
BSJ Dennis Xu [Xiamen Compower Medical Tech. Co., Ltd.]	Anesthesia mask	2010-03-01

Related Finance Registrations

NCAGE Code	SDQR1	XIAMEN COMPOWER MEDICAL TECH.CO.,LTD
CAGE Code	SDQR1	XIAMEN COMPOWER MEDICAL TECH.CO.,LTD

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092629447	Xiamen,China (Mainland) -> New York/Newark Area, Newark, New Jersey	MASK	149 CTN
2019122354252	Xiamen,China (Mainland) -> Tacoma, Washington	DEMONSTRATION RESUSCITATORS FOR CPR MANIKINS THIS SHIPMENT CONTAINS NO SOLID WOOD PACKING MATERIALS	848 CTN
2019062643687	Xiamen,China (Mainland) -> Tacoma, Washington	DEMONSTRATION RESUSCITATORS FOR CPR MANIKINS THIS SHIPMENT CONTAINS NO SOLID WOOD PACKING MATERIALS	1130 CTN
2019062459710	Xiamen,China (Mainland) -> Tacoma, Washington	DEMONSTRATION RESUSCITATORS FOR CPR MANIKINS THIS SHIPMENT CONTAINS NO SOLID WOOD PACKING MATERIALS	1130 CTN
2019042622871	Xiamen,China (Mainland) -> Los Angeles, California	DEMONSTRATION RESUSCITATORS FOR CPR MANIKINS THIS SHIPMENT CONTAINS NO SOLID WOOD PACKING MATERIALS	643 CTN
2019042427183	Xiamen,China (Mainland) -> Los Angeles, California	DEMONSTRATION RESUSCITATORS FOR CPR MANIKINS THIS SHIPMENT CONTAINS NO SOLID WOOD PACKING MATERIALS	643 CTN
2018111918544	Kaohsiung,China (Taiwan) -> Tacoma, Washington	DEMONSTRATION RESUSCITATORS FOR CPR MANIKINS THIS SHIPMENT CONTAINS NO SOLID WOOD PACKING MATERIALS	629 CTN
2018062937981	Kaohsiung,China (Taiwan) -> Tacoma, Washington	DEMONSTRATION RESUSCITATORS FOR CPR MANIKINS PP BOX THIS SHIPMENT CONTAINS NO SOLID WOOD PACKING MATERIALS	385 CTN