Xiamen World Gear Sports Goods Co L T D

FDA Filings

This page includes the latest FDA filings for Xiamen World Gear Sports Goods 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: 3004168774
• FEI Number: 3004168774
• Name: XIAMEN WORLD GEAR SPORTS GOODS CO., LTD
• Owner & Operator: XIAMEN WORLD GEAR SPORTS GOODS CO., LTD
• Contact Address: 27-29 NORTH 2ND ROAD --; XIAMEN CN-35 Fujian 361022 CN
• Official Correspondent:
  • LUCA - TONARINI
  • 86-592-6242337-x
• US Agent:
  • Michael Gayetsky
  • 330 3987476
  • Michaelgayetsky@hotmail.com
• Importing Logistics Registration:
  • Importer: Compass Health Brands
  • Address: 6753 Engle Road ; Middleburg Heights, OH 44130 UNITED STATES
• Importing Logistics Registration:
  • Importer: GARDEN CITY MEDICAL, INC. Also Trading As PMI
  • Address: 770 Tipton Road Suite A ; Lawrenceville, GA 30046 UNITED STATES
• Importing Logistics Registration:
  • Importer: INVACARE CORP.
  • Address: ONE INVACARE WAY ; Elyria, OH 44036 UNITED STATES
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 27-29 NORTH 2ND ROAD ; XIAMEN Fujian, 361022 CN
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 06974512010014 XIAMEN WORLD GEAR SPORTS GOODS CO., LTD	Proactive	2023-07-26
OSI XIAMEN WORLD GEAR SPORTS GOODS CO., LTD	PrimePlus2002	2011-05-04
OSI XIAMEN WORLD GEAR SPORTS GOODS CO., LTD	PrimePlus1752	2011-05-04
OSI XIAMEN WORLD GEAR SPORTS GOODS CO., LTD	PrimePlus1750	2011-05-04
OSI XIAMEN WORLD GEAR SPORTS GOODS CO., LTD	ML750 / PrimePlus1750	2011-05-04
OSI XIAMEN WORLD GEAR SPORTS GOODS CO., LTD	ML1000 / PrimePlus2000	2011-05-04
OSI XIAMEN WORLD GEAR SPORTS GOODS CO., LTD	BAR5301 IVC	2011-05-04
FNL XIAMEN WORLD GEAR SPORTS GOODS CO., LTD	TL500	2009-07-30
FNL XIAMEN WORLD GEAR SPORTS GOODS CO., LTD	TL500 / PrimeCare900	2009-07-30
FNL XIAMEN WORLD GEAR SPORTS GOODS CO., LTD	PrimeCare902	2009-07-30
FNL XIAMEN WORLD GEAR SPORTS GOODS CO., LTD	PrimeCare901	2009-07-30
FNL XIAMEN WORLD GEAR SPORTS GOODS CO., LTD	PrimeCare601	2009-07-30
FNL XIAMEN WORLD GEAR SPORTS GOODS CO., LTD	PrimeCare301	2009-07-30
FNL XIAMEN WORLD GEAR SPORTS GOODS CO., LTD	PrimeCare Bed Model P903	2009-07-30
FNL XIAMEN WORLD GEAR SPORTS GOODS CO., LTD	PrimeCare Bed Model P703	2009-07-30
FNL XIAMEN WORLD GEAR SPORTS GOODS CO., LTD	PrimeCare Bed Model P503	2009-07-30
FNL XIAMEN WORLD GEAR SPORTS GOODS CO., LTD	LAB903	2009-07-30
FNL XIAMEN WORLD GEAR SPORTS GOODS CO., LTD	LAB703	2009-07-30
FNL XIAMEN WORLD GEAR SPORTS GOODS CO., LTD	LAB503	2009-07-30
FNL XIAMEN WORLD GEAR SPORTS GOODS CO., LTD	EL600 / PrimeCare200	2009-07-30
FNL XIAMEN WORLD GEAR SPORTS GOODS CO., LTD	5301 LOW	2009-07-30
FNL XIAMEN WORLD GEAR SPORTS GOODS CO., LTD	5301 IVC	2009-07-30
FSA XIAMEN WORLD GEAR SPORTS GOODS CO., LTD	STS450 / PrimeCare L450-STS	2003-10-02
FSA XIAMEN WORLD GEAR SPORTS GOODS CO., LTD	RPS440US	2003-10-02
FSA XIAMEN WORLD GEAR SPORTS GOODS CO., LTD	ML600 / PrimePlus L1600	2003-10-02
FSA XIAMEN WORLD GEAR SPORTS GOODS CO., LTD	ML450 / PrimeCare L450	2003-10-02
FSA XIAMEN WORLD GEAR SPORTS GOODS CO., LTD	INVACARE	2003-10-02
FSA XIAMEN WORLD GEAR SPORTS GOODS CO., LTD	GET-U-UP Lifter	2003-10-02
FSA XIAMEN WORLD GEAR SPORTS GOODS CO., LTD	9805P	2003-10-02
FSA XIAMEN WORLD GEAR SPORTS GOODS CO., LTD	9805	2003-10-02
FSA XIAMEN WORLD GEAR SPORTS GOODS CO., LTD	32475 Hydraulic Patient Lift	2003-10-02