Vatech Co L T D

FDA Filings

This page includes the latest FDA filings for Vatech 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: 3004706313
• FEI Number: 3004706313
• Name: VATECH CO., LTD.
• Owner & Operator: VATECH CO., LTD.
• Contact Address: 13, Samsung 1-ro 2-gil ; Hwaseong-si KR-41 Gyeonggido 18449 KR
• US Agent:
  • Dave Kim
  • Mtech Group
  • 713 4672607
  • davekim@mtech-inc.net
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 13, Samsung 1-ro, 2-gil ; Hwaseong-si Gyeonggido, 18449 KR
• Establishment Type:
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 08800016400571 VATECH CO., LTD.	PaX-i	2024-03-18
GUDID 08800016400564 VATECH CO., LTD.	PaX-i	2024-03-18
GUDID 08800016400557 VATECH CO., LTD.	PaX-i	2024-03-18
GUDID 08800016400496 VATECH CO., LTD.	EzRay Air	2024-03-18
GUDID 08800016400342 VATECH CO., LTD.	ProVecta HD	2024-03-18
GUDID 08800016400335 VATECH CO., LTD.	ProVecta HD	2024-03-18
GUDID 08800016400328 VATECH CO., LTD.	ProVecta HD	2024-03-18
GUDID 08800016400311 VATECH CO., LTD.	ProVecta S-Pan	2024-03-18
GUDID 08800016400304 VATECH CO., LTD.	ProVecta S-Pan	2024-03-18
GUDID 08800016400298 VATECH CO., LTD.	PaX-i	2024-03-18
GUDID 08800016400281 VATECH CO., LTD.	PaX-i	2024-03-18
GUDID 08800016400250 VATECH CO., LTD.	PaX-i3D	2024-03-18
GUDID 08800016400243 VATECH CO., LTD.	PaX-i3D	2024-03-18
GUDID 08800016400212 VATECH CO., LTD.	PaX-i3D	2024-03-18
GUDID 08800016400205 VATECH CO., LTD.	PaX-i3D	2024-03-18
GUDID 08800016400137 VATECH CO., LTD.	PaX-i3D Green	2024-03-18
GUDID 08800016400106 VATECH CO., LTD.	PaX-i3D Green	2024-03-18
GUDID 08800016400090 VATECH CO., LTD.	PaX-i3D Green	2024-03-18
GUDID 08800016400083 VATECH CO., LTD.	PaX-i3D Green	2024-03-18
GUDID 08800016400076 VATECH CO., LTD.	PaX-i3D Green	2024-03-18
GUDID 08800016400069 VATECH CO., LTD.	PaX-i3D Green	2024-03-18
GUDID 08800016400588 VATECH CO., LTD.	Green Smart	2024-02-19
GUDID 08800016400489 VATECH CO., LTD.	EzRay Air W	2024-02-19
GUDID 08800016400472 VATECH CO., LTD.	EzRay Air W	2024-02-19
GUDID 08800016400465 VATECH CO., LTD.	EzRay Air W	2024-02-19
GUDID 08800016400458 VATECH CO., LTD.	PaX-i Insight	2024-02-19
GUDID 08800016400441 VATECH CO., LTD.	PaX-i Insight	2024-02-19
GUDID 08800016400434 VATECH CO., LTD.	PaX-i Plus	2024-02-19
GUDID 08800016400427 VATECH CO., LTD.	PaX-i Plus	2024-02-19
GUDID 08800016400410 VATECH CO., LTD.	Green 18	2024-02-19
GUDID 08800016400403 VATECH CO., LTD.	Green 18	2024-02-19
GUDID 08800016400397 VATECH CO., LTD.	Green 16	2024-02-19
GUDID 08800016400380 VATECH CO., LTD.	Green 16	2024-02-19
GUDID 08800016400373 VATECH CO., LTD.	Green Smart	2024-02-19
GUDID 08800016400366 VATECH CO., LTD.	Green Smart	2024-02-19
GUDID 08800016400359 VATECH CO., LTD.	PaX-i3D Green Premium / Green 21	2024-02-19
GUDID 08800016400021 VATECH CO., LTD.	PaX-i3D Smart	2024-02-19
GUDID 08800016400014 VATECH CO., LTD.	PaX-i3D Smart	2024-02-19
GUDID 08800016400007 VATECH CO., LTD.	PaX-i3D Smart	2024-02-19
GUDID 08800016401844 VATECH CO., LTD.	Green X 12	2023-08-29
GUDID 08800016401837 VATECH CO., LTD.	Green X 12	2023-08-29
GUDID 08800016401929 VATECH CO., LTD.	EzRay Air 2 Wall	2023-06-26
GUDID 08800016401912 VATECH CO., LTD.	EzRay Air 2 Wall	2023-06-26
GUDID 08800016401905 VATECH CO., LTD.	EzRay Air 2 Wall	2023-06-26
GUDID 08800016401899 VATECH CO., LTD.	VistaIntra DC	2023-06-26
GUDID 08800016401882 VATECH CO., LTD.	VistaIntra DC	2023-06-26
GUDID 08800016401875 VATECH CO., LTD.	VistaIntra DC	2023-06-26
GUDID 08800016401868 VATECH CO., LTD.	VistaPano	2023-06-26
GUDID 08800016401851 VATECH CO., LTD.	VistaPano	2023-06-26
GUDID 08800016401288 VATECH CO., LTD.	EzRay M	2023-06-26
PMN K223058 Vatech Co., Ltd	EzRay Air 2 Wall (Model: VEX-S350W)	2022-10-26
GUDID 08800016400717 VATECH CO., LTD.	Green X	2022-08-03
GUDID 08800016400700 VATECH CO., LTD.	Green X	2022-08-03
PMN K213462 Vatech Co., Ltd	EzRay M18 (Model: VMX-P400)	2022-02-11
GUDID 08800016401325 VATECH CO., LTD.	Smart Plus	2021-06-29
GUDID 08800016401318 VATECH CO., LTD.	Smart Plus	2021-06-29
GUDID 08800016401301 VATECH CO., LTD.	Smart Plus	2021-06-29
GUDID 08800016401103 VATECH CO., LTD.	vatech A9	2021-06-29
GUDID 08800016401097 VATECH CO., LTD.	vatech A9	2021-06-29
GUDID 08800016400601 VATECH CO., LTD.	Green 16	2021-06-22
GUDID 08800016400595 VATECH CO., LTD.	Green 16	2021-06-22
GUDID 08800016400793 VATECH CO., LTD.	Green X 18	2021-06-02
GUDID 08800016400786 VATECH CO., LTD.	Green X 18	2021-06-02
PMN K210329 Vatech Co., Ltd	Green X 18(Model : PHT-75CHS)	2021-02-18
PMN K203797 Vatech Co., Ltd	Vatech A9 (Model : PHT-30CSS)	2021-01-25
PMN K201627 Vatech Co., Ltd	Dental Computed Tomography X-Ray System, Green X	2020-10-27
PMN K200182 | EHD VATECH CO., LTD.	EzRay Air Portable	2020-04-16
GUDID 08800016400694 VATECH CO., LTD.	EzRay Air	2020-03-20
PMN K200182 Vatech Co., Ltd	EzRay Air Portable (Model: VEX-P300)	2020-02-11
GUDID 08800016400656 VATECH CO., LTD.	EzRay Air W	2019-04-02
GUDID 08800016400649 VATECH CO., LTD.	EzRay Air W	2019-04-02
GUDID 08800016400632 VATECH CO., LTD.	EzRay Air W	2019-04-02
GUDID 08800016400625 VATECH CO., LTD.	PaX-i3D Smart	2019-03-29
GUDID 08800016400618 VATECH CO., LTD.	PaX-i3D Smart	2019-03-29
PMN K170066 | OAS VATECH CO., LTD.	Green16/Green18 (Model: PHT-65LHS)	2017-06-25
PMN K170066 VATECH CO., LTD.	Green16/Green18 (Model: PHT-65LHS)	2017-06-16
PMN K170731 | MUH VATECH CO., LTD.	PaX-i Plus/PaX-i Insight (Model: PCH-30CS)	2017-05-26
PMN K163705 | EHD VATECH CO., LTD.	EzRay Air Wall (Model: VEX-S300W)	2017-05-26
PMN K162660 | OAS VATECH CO., LTD.	Smart Plus (Model: PHT-35LHS)	2017-05-26
PMN K161063 | EHD VATECH CO., LTD.	EzRay Air Portable (Model: VEX-P300)	2017-05-26
PMN K160882 | OAS VATECH CO., LTD.	Green21 (Model: PCT-90LH)	2017-05-26
PMN K170731 Vatech Co., Ltd	System, X-Ray, Extra Oral Source, Digital, PaX-i Plus, PaX-i Insight	2017-04-04
PMN K163705 Vatech Co., Ltd	EzRay Air W	2017-01-24
PMN K160882 VATECH CO., LTD	PaX-i3D Green Premium (Model: PCT-90LH)	2016-10-28
PMN K162660 VATECH CO., LTD	Green Smart (Model: PHT-35LHS)	2016-10-20
PMN K161063 Vatech Co., Ltd	EzRay Air (Model VEX-P300)	2016-09-01
PMN K152106 | OAS VATECH CO., LTD.	PaX-i3D Smart (Model:PHT-30LFO)	2015-12-17
PMN K152106 VATECH CO., LTD	Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart	2015-10-23
PMN K132983 VATECH CO., LTD.	TON-95LH, PAX-I3D ORTHO	2014-08-07
PMN K130585 VATECH CO., LTD.	PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM, PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM	2013-07-15
PMN K130432 VATECH CO., LTD.	PHT-6500, PHT-60CFO	2013-05-31
PMN K123493 VATECH CO., LTD.	VEX-S 100W INTRAORAL X-RAY SYSTEM	2012-12-13
PMN K122155 VATECH CO., LTD.	PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM	2012-09-04
PMN K121400 VATECH CO., LTD.	PAX-UNI3D, PHT-7500	2012-08-28
PMN K121412 VATECH CO., LTD.	PAX-FLEX3D, PHT-7000	2012-06-08
PMN K121236 VATECH CO., LTD.	PAX-DUO3D PLUS, PCT-5000	2012-05-24
PMN K113672 VATECH CO., LTD.	PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM	2012-03-27
PMN K102078 VATECH CO., LTD.	RADIOLOGICAL IMAGE PROCESSING SYSTEM	2011-08-10
PMN K102196 VATECH CO., LTD.	COMPUTED TOMOGRAPHY X-RAY SYSTEM	2011-03-25
PMN K102102 VATECH CO., LTD.	COMPUTED TOMOGRAPHY X-RAY SYSTEM	2011-03-11
PMN K102259 VATECH CO., LTD.	DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM	2011-02-18
PMN K101590 VATECH CO., LTD.	DIGITAL FLAT PANEL X-RAY DETECTOR	2010-11-29
PMN K102124 VATECH CO., LTD.	DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM	2010-10-22
PMN K092830 VATECH CO., LTD.	DIGITAL X-RAY IMAGING SYSTEM, MODEL DRC-1000	2010-07-21
PMN K100317 VATECH CO., LTD.	DIGITAL X-RAY IMAGING SYSTEM (PAX-PRIMO) MODEL PAX-PRIMO	2010-03-24
PMN K090467 VATECH CO., LTD.	DIGITAL X-RAY IMAGING SYSTEM, MODEL PAX-UNI3D	2010-01-08
PMN K092103 VATECH CO., LTD.	DENTAL EXTRAORAL SOURCE X-RAY SYSTEM (ESX)	2009-10-09
PMN K082350 VATECH CO., LTD.	PAX-500	2008-10-10
PMN K073365 VATECH CO., LTD.	DENTAL DIGITAL X-RAY IMAGING SYSTEM	2008-04-08

Similar & Related FDA Registered Companies

• VATECH VALUE ADDED TECHNOLOGY CO., LTD
• Vatech mcis Co., Ltd

Related Finance Registrations

NCAGE Code	2M26F	VATECH CO., LTD.
CAGE Code	2M26F	VATECH CO., LTD.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020091492285	Pusan,South Korea -> Los Angeles, California	SPARE PARTS FOR DIGITAL DENTAL X-RAY EQUIPMEN T	20 PKG
2020091188709	Pusan,South Korea -> Los Angeles, California	DIGITAL X RAY	36 PKG
2020091188709	Pusan,South Korea -> Los Angeles, California	DIGITAL X RAY	36 PKG
2020091066253	Pusan,South Korea -> Los Angeles, California	DIGITAL X RAY	18 PKG
2020082061821	Pusan,South Korea -> Los Angeles, California	DIGITAL X RAY	3 PKG
2020081747972	Pusan,South Korea -> Long Beach, California	DIGITAL X RAY	20 PKG
2020081592775	Pusan,South Korea -> Los Angeles, California	AUTO PARTS OF BODIES	19 PKG
2020080756413	Pusan,South Korea -> Long Beach, California	DIGITAL X RAY	4 PKG
2020071461428	Pusan,South Korea -> Los Angeles, California	SPARE PARTS FOR DIGITAL DENTAL X-RAY EQUIPMEN T	20 PKG