Dexcowin Co L T D

FDA Filings

This page includes the latest FDA filings for Dexcowin 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: 3007065358
• FEI Number: 3007065358
• Name: Joyce St Germain
• Owner & Operator: Dexcowin Co., Ltd.
• Contact Address: 905, 2 Gasan digital 1-ro Geumcheon-gu; Seoul KR-NOTA 08591 KR
• Official Correspondent:
  • Seung-Bum Ryu
  • 82-2-20272880-x
• US Agent:
  • Joyce St Germain
  • The 510k Consulting LLC
  • 904 4773203
  • joyce510kfda@gmail.com
• Importing Logistics Registration:
  • Importer: Archer Dental
  • Address: 1107 Summit Ave. Suite 1 ; Plano, TX 75074 UNITED STATES
  • Importer Type: Retailer
• Importing Logistics Registration:
  • Importer: Dexcowin Global, Inc.
  • Address: Office # 878 Regus Center 155 N Lake Ave., Suite 800 ; Pasadena, CA 91101 UNITED STATES
  • Importer Type: RETAILER
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1449 Springleaf Drive ; Ormond Beach, FL 32174 US
• Establishment Type:
  • Repack or Relabel Medical Device
  • Manufacture Medical Device
  • Export Device to the United States But Perform No Other Operation on Device

FDA Filings

Device Company	Device	Date
PMN K173046 Dexcowin Co., Ltd.	Cocoon Portable Handheld X-Ray System	2017-10-26
PMN K143494 | IZL Joyce St Germain [Dexcowin Co., Ltd.]	ADX6000	2017-01-16
IYB Joyce St Germain [Dexcowin Co., Ltd.]	AllMy T Stand	2015-11-25
EJF Joyce St Germain [Dexcowin Co., Ltd.]	Tiggle	2015-11-25
PMN K143494 DEXCOWIN CO., LTD	ADX6000 Portable X-Ray System; IRayA6	2015-10-05
PMN K140060 | MUH Joyce St Germain [Dexcowin Co., Ltd.]	Rex 2	2014-11-07
PMN K140060 | MQB Joyce St Germain [Dexcowin Co., Ltd.]	Rex 2	2014-11-07
PMN K134055 | MUH Joyce St Germain [Dexcowin Co., Ltd.]	iRay D4	2014-11-07
PMN K134055 | MUH Joyce St Germain [Dexcowin Co., Ltd.]	ADX 4000	2014-11-07
PMN K133007 | MUH Joyce St Germain [Dexcowin Co., Ltd.]	iRay D3	2014-11-07
PMN K133007 | MUH Joyce St Germain [Dexcowin Co., Ltd.]	DX3000	2014-11-07
NOF Joyce St Germain [Dexcowin Co., Ltd.]	iCam Plus	2014-11-07
NOF Joyce St Germain [Dexcowin Co., Ltd.]	RayCam	2014-11-07
PMN K134055 DEXCOWIN CO., LTD	ADX4000W	2014-05-09
PMN K133007 DEXCOWIN CO., LTD	DX3000-L	2014-04-24
PMN K083532 | MUH Joyce St Germain [Dexcowin Co., Ltd.]	X-Ray2go	2009-03-19
PMN K083532 DEXCOWIN CO., LTD	ADX4000-L, DX3000-L	2009-03-10
PMN K070811 | MUH Joyce St Germain [Dexcowin Co., Ltd.]	iRay D4	2008-05-26
PMN K070811 | MUH Joyce St Germain [Dexcowin Co., Ltd.]	iRay D3	2008-05-26
PMN K070811 | MUH Joyce St Germain [Dexcowin Co., Ltd.]	DX3000	2008-05-26
PMN K070811 | MUH Joyce St Germain [Dexcowin Co., Ltd.]	DX3000-OP	2008-05-26
PMN K070811 | MUH Joyce St Germain [Dexcowin Co., Ltd.]	ADX4000-OP	2008-05-26
PMN K070811 | MUH Joyce St Germain [Dexcowin Co., Ltd.]	ADX4000-L	2008-05-26

Related Finance Registrations

NCAGE Code	2L65F	DEXCOWIN CO.,LTD
CAGE Code	2L65F	DEXCOWIN CO.,LTD