Gn Resound China L T D

FDA Filings

This page includes the latest FDA filings for Gn Resound China 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: 3003303986
• FEI Number: 3003303986
• Name: GN RESOUND CHINA, LTD.
• Owner & Operator: GN Hearing A/S
• Contact Address: Lautrupbjerg 7 ; Ballerup DK-84 Region Hovedstaden 2750 DK
• Official Correspondent:
  • Lars Hagander
  • 45-45-752100-x
• US Agent:
  • ANDREW KLAPPERICK
  • 952 7698136
  • aklapperick@gnresound.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 15 CHUANG XIN ROAD-CPA AREA ; XIAMEN Fujian, 361006 CN
• Establishment Type:
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K181586 | KLW GN RESOUND CHINA, LTD. [GN Hearing A/S]	Tinnitus Sound Generator Module	2019-02-27
PMN K180495 | KLW GN RESOUND CHINA, LTD. [GN Hearing A/S]	Tinnitus Sound Generator Module	2019-02-27
PMN K150171 | KLW GN RESOUND CHINA, LTD. [GN Hearing A/S]	Tinnitus Sound Generator Module	2015-11-03
PMN K110932 | KLW GN RESOUND CHINA, LTD. [GN Hearing A/S]	Tinnitus Sound Generator Module	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	Vida	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	Vea	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	USB FITTING DONGLE	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	UP	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	UP Smart	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	Trust	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	TV STREAMER 2	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	TV LINK 2	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	TV 2	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	TV 2 UNITE	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	TV 2 STREAMER	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	Sola	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	Saxo	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	RS UNITE PHONE CLIP	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	RS UNITE MINI MIC	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	REMOTE CONTROL 3	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	REMOTE CONTROL 2	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	RC-2	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	Promise	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	Preza	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	PHONE LINK 2	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	PHONE CLIP PLUS	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	Magna	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	MYPAL PRO	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	MYPAL MICRO	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	MULTI MIC	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	MINI MIC	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	MICRO MIC	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	Lively	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	LiNX	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	LiNX Quattro	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	LiNX 3D	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	LiNX 2	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	Legend	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	Kirkland Signature 6	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	Kirkland Signature 5	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	Future	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	Forza	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	Forte	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	Flyte	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	First	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	Enya	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	ENZO Q	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	ENZO 3D	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	ENZO 2	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	Cala	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	COSTCO CLIP-ON MIC	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	C-1	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	Boost Ultra	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	Boost Plus	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	Boost Max	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	BT BLUETOOTH BRIDGE-2	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	BT AUDIO LINK	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	BLUETOOTH BRIDGE-2	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	Amaze	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	Ally	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	ASM AIRLINK 2	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	AIRLINK	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	AIRLINK 2	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	AGXR-Y	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	AGXR-T	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	AGXR-N	2011-11-22
OSM GN RESOUND CHINA, LTD. [GN Hearing A/S]	AGXR Q	2011-11-22
PMN K073636 | KLW GN RESOUND CHINA, LTD. [GN Hearing A/S]	Tinnitus Sound Generator Module	2008-06-23
LRB GN RESOUND CHINA, LTD. [GN Hearing A/S]	Generic Faceplate	1994-09-15
ESD GN RESOUND CHINA, LTD. [GN Hearing A/S]	Vivid	1989-05-31
ESD GN RESOUND CHINA, LTD. [GN Hearing A/S]	Vivid Stratus	1989-05-31
ESD GN RESOUND CHINA, LTD. [GN Hearing A/S]	Vea	1989-05-31
ESD GN RESOUND CHINA, LTD. [GN Hearing A/S]	Trust	1989-05-31
ESD GN RESOUND CHINA, LTD. [GN Hearing A/S]	Sola	1989-05-31
ESD GN RESOUND CHINA, LTD. [GN Hearing A/S]	Saxo	1989-05-31
ESD GN RESOUND CHINA, LTD. [GN Hearing A/S]	Promise	1989-05-31
ESD GN RESOUND CHINA, LTD. [GN Hearing A/S]	Origin	1989-05-31
ESD GN RESOUND CHINA, LTD. [GN Hearing A/S]	LiNX 3D	1989-05-31
ESD GN RESOUND CHINA, LTD. [GN Hearing A/S]	LiNX 2	1989-05-31
ESD GN RESOUND CHINA, LTD. [GN Hearing A/S]	Legend	1989-05-31
ESD GN RESOUND CHINA, LTD. [GN Hearing A/S]	Forza	1989-05-31
ESD GN RESOUND CHINA, LTD. [GN Hearing A/S]	Forte	1989-05-31
ESD GN RESOUND CHINA, LTD. [GN Hearing A/S]	Flyte	1989-05-31
ESD GN RESOUND CHINA, LTD. [GN Hearing A/S]	Enya	1989-05-31
ESD GN RESOUND CHINA, LTD. [GN Hearing A/S]	Cala	1989-05-31
ESD GN RESOUND CHINA, LTD. [GN Hearing A/S]	Bold	1989-05-31
ESD GN RESOUND CHINA, LTD. [GN Hearing A/S]	Ally	1989-05-31
ESD GN RESOUND CHINA, LTD. [GN Hearing A/S]	AGXR-Y	1989-05-31
ESD GN RESOUND CHINA, LTD. [GN Hearing A/S]	AGXR-T	1989-05-31

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020010840145	Xiamen,China (Mainland) -> Tacoma, Washington	SPARE PARTS OF HEARING AIDS SPARE PARTS OF HEARING AIDS HS CODE :8543209090 8543902900	6 PKG
2019111928174	Xiamen,China (Mainland) -> Tacoma, Washington	SPARE PARTS OF HEARING AIDS SPARE PARTS OF HEARING AIDS HS CODE:8543209090 8543902900	8 PKG