Sun Medical Co L T D

FDA Filings

This page includes the latest FDA filings for Sun Medical 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: 8030419
• FEI Number: 3002973484
• Name: SUN MEDICAL CO., LTD.
• Owner & Operator: SUN MEDICAL CO., LTD.
• Contact Address: 571-2 FURUTAKA-CHO MORIYAMA; SHIGA JP-NOTA 524-0044 JP
• US Agent:
  • Michael Van de Woude
  • Emergo Global Representation LLC
  • 512 3279997
  • 512 3279998
  • USAgent@ul.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 571-2 FURUTAKA-CHO ; MORIYAMA Siga, 524-0044 JP
• Establishment Type: Manufacture Medical Device

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
GUDID 04560227798990 SUN MEDICAL CO.,LTD.	Coating Material KS51US	2018-08-09
GUDID 14560227799300 SUN MEDICAL CO.,LTD.	Acrylic Block TS33US	2018-05-24
GUDID 14560227799294 SUN MEDICAL CO.,LTD.	Acrylic Block TS32US	2018-05-24
GUDID 14560227799287 SUN MEDICAL CO.,LTD.	Acrylic Block TS31US	2018-05-24
GUDID 14560227799270 SUN MEDICAL CO.,LTD.	Acrylic Block TS25US	2018-05-24
GUDID 14560227799263 SUN MEDICAL CO.,LTD.	Acrylic Block TS23US	2018-05-24
GUDID 14560227799256 SUN MEDICAL CO.,LTD.	Acrylic Block TS21US	2018-05-24
GUDID 14560227799249 SUN MEDICAL CO.,LTD.	Acrylic Block TS15US	2018-05-24
GUDID 14560227799232 SUN MEDICAL CO.,LTD.	Acrylic Block TS13US	2018-05-24
GUDID 14560227799225 SUN MEDICAL CO.,LTD.	Acrylic Block TS11US	2018-05-24
GUDID 14560227799218 SUN MEDICAL CO.,LTD.	Acrylic Block TS05US	2018-05-24
GUDID 14560227799201 SUN MEDICAL CO.,LTD.	Acrylic Block TS03US	2018-05-24
GUDID 14560227799195 SUN MEDICAL CO.,LTD.	Acrylic Block TS01US	2018-05-24
PMN K151518 | KLE SUN MEDICAL CO., LTD.	Brush & Bond UNIVERSAL	2015-11-17
PMN K150511 SUN MEDICAL CO., LTD	Coating Material	2015-05-27
PMN K143265 SUN MEDICAL CO., LTD.	Acrylic Block	2015-04-14
PMN K900303 | EMA SUN MEDICAL CO., LTD.	C & B Metabond	2007-12-05
PMN K060946 | KIF SUN MEDICAL CO., LTD.	Metaseal	2007-12-05
PMN K020239 | KLE SUN MEDICAL CO., LTD.	Brush and Bond	2007-12-05

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• SUNEVA MEDICAL, INC.5879 Pacific Center Blvd.san Diego, CA 92121 PMA NumberP020012 Supplement NumberS041 Date Received07/08/2022 Decision Date08/05/2022 Product Code LMH  Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No