Suntech Medical Inc

FDA Filings

This page includes the latest FDA filings for Suntech Medical Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Suntech Medical Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• SUNTECH MEDICAL DEVICES (SHENZHEN) CO., LTD.

FDA Registration(s)

• Registration Number: 1036863
• FEI Number: 1036863
• Name: SUNTECH MEDICAL, INC.
• Owner & Operator: SUNTECH MEDICAL, INC.
• Contact Address: 507 AIRPORT BOULEVARD SUITE 117; Morrisville NC 27560 US
• Official Correspondent:
  • CHARLES B SETZER
  • x-919-6542300-334
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 507 AIRPORT BLVD STE 117 ; MORRISVILLE, NC 27560 US
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Device in the United States for Export Only

FDA Filings

Device Company	Device	Date
GUDID 10840935110446 SUNTECH MEDICAL, INC.	SunTech APC	2023-06-19
GUDID 10840935110439 SUNTECH MEDICAL, INC.	SunTech APC	2023-06-19
GUDID 10840935110422 SUNTECH MEDICAL, INC.	SunTech APC	2023-06-19
GUDID 10840935110415 SUNTECH MEDICAL, INC.	SunTech APC	2023-06-19
GUDID 10840935110408 SUNTECH MEDICAL, INC.	SunTech APC	2023-06-19
GUDID 10840935110392 SUNTECH MEDICAL, INC.	SunTech APC	2023-06-19
GUDID 10840935110385 SUNTECH MEDICAL, INC.	SunTech APC	2023-06-19
GUDID 10840935110378 SUNTECH MEDICAL, INC.	SunTech APC	2023-06-19
GUDID 10840935110361 SUNTECH MEDICAL, INC.	SunTech APC	2023-06-19
GUDID 10840935110354 SUNTECH MEDICAL, INC.	SunTech APC	2023-06-19
GUDID 10840935110347 SUNTECH MEDICAL, INC.	SunTech APC	2023-06-19
GUDID 10840935110330 SUNTECH MEDICAL, INC.	SunTech APC	2023-06-19
GUDID 10840935110323 SUNTECH MEDICAL, INC.	SunTech APC	2023-06-19
GUDID 10840935110316 SUNTECH MEDICAL, INC.	SunTech APC	2023-06-19
GUDID 10840935110309 SUNTECH MEDICAL, INC.	SunTech APC	2023-06-19
GUDID 10840935110293 SUNTECH MEDICAL, INC.	SunTech APC	2023-06-19
GUDID 10840935110286 SUNTECH MEDICAL, INC.	SunTech APC	2023-06-19
GUDID 10840935110279 SUNTECH MEDICAL, INC.	SunTech APC	2023-06-19
GUDID 10840935110262 SUNTECH MEDICAL, INC.	ProLife	2023-06-19
GUDID 10840935110255 SUNTECH MEDICAL, INC.	ProLife	2023-06-19
GUDID 10840935110248 SUNTECH MEDICAL, INC.	ProLife	2023-06-19
GUDID 10840935110231 SUNTECH MEDICAL, INC.	ProLife	2023-06-19
GUDID 10840935110224 SUNTECH MEDICAL, INC.	SunTech APC	2023-06-19
GUDID 10840935110217 SUNTECH MEDICAL, INC.	ProLife	2023-06-19
GUDID 10840935110200 SUNTECH MEDICAL, INC.	MD	2023-05-17
GUDID 10840935110194 SUNTECH MEDICAL, INC.	MD	2023-05-17
GUDID 10840935110187 SUNTECH MEDICAL, INC.	MD	2023-05-17
GUDID 10840935110170 SUNTECH MEDICAL, INC.	MD	2023-05-17
GUDID 10840935110163 SUNTECH MEDICAL, INC.	MD	2023-05-17
GUDID 10840935110156 SUNTECH MEDICAL, INC.	MD	2023-05-11
GUDID 10840935110149 SUNTECH MEDICAL, INC.	Orbit-K	2023-04-03
GUDID 10840935110132 SUNTECH MEDICAL, INC.	Orbit-K	2023-04-03
GUDID 10840935110125 SUNTECH MEDICAL, INC.	Orbit-K	2023-04-03
GUDID 10840935110118 SUNTECH MEDICAL, INC.	Orbit-K	2023-04-03
GUDID 10840935110101 SUNTECH MEDICAL, INC.	Orbit-K	2023-03-10
GUDID 10840935110095 SUNTECH MEDICAL, INC.	Orbit-K	2023-03-10
GUDID 10840935110088 SUNTECH MEDICAL, INC.	Orbit-K	2023-03-10
GUDID 10840935110071 SUNTECH MEDICAL, INC.	Orbit-K	2023-03-10
GUDID 10840935110064 SUNTECH MEDICAL, INC.	Orbit-K	2023-03-10
GUDID 10840935110057 SUNTECH MEDICAL, INC.	Orbit-K	2023-03-10
GUDID 10840935110040 SUNTECH MEDICAL, INC.	Orbit-K	2023-03-10
GUDID 10840935110033 SUNTECH MEDICAL, INC.	Orbit-K	2023-03-10
GUDID 10840935110019 SUNTECH MEDICAL, INC.	Tango M2	2023-03-09
GUDID 10840935109990 SUNTECH MEDICAL, INC.	Seiva	2022-11-08
GUDID 10840935109983 SUNTECH MEDICAL, INC.	SunTech	2022-11-08
GUDID 10840935109976 SUNTECH MEDICAL, INC.	SunTech	2022-11-08
GUDID 10840935109969 SUNTECH MEDICAL, INC.	SunTech	2022-11-08
GUDID 10840935109952 SUNTECH MEDICAL, INC.	Oscar 2	2022-09-05
GUDID 10840935109945 SUNTECH MEDICAL, INC.	Oscar 2	2022-09-05
GUDID 10840935109938 SUNTECH MEDICAL, INC.	Oscar 2	2022-09-05
GUDID 10840935109921 SUNTECH MEDICAL, INC.	Oscar 2	2022-09-05
GUDID 10840935109914 SUNTECH MEDICAL, INC.	SunTech	2022-04-27
GUDID 10840935109792 SUNTECH MEDICAL, INC.	All Purpose Cuff	2022-01-11
GUDID 10840935109730 SUNTECH MEDICAL, INC.	All Purpose Cuff	2022-01-11
GUDID 10840935109907 SUNTECH MEDICAL, INC.	All Purpose Cuff	2021-10-22
GUDID 10840935109891 SUNTECH MEDICAL, INC.	All Purpose Cuff	2021-10-22
GUDID 10840935109884 SUNTECH MEDICAL, INC.	All Purpose Cuff	2021-10-22
GUDID 10840935109877 SUNTECH MEDICAL, INC.	All Purpose Cuff	2021-10-22
GUDID 10840935109860 SUNTECH MEDICAL, INC.	All Purpose Cuff	2021-10-22
GUDID 10840935109853 SUNTECH MEDICAL, INC.	All Purpose Cuff	2021-10-22
GUDID 10840935109846 SUNTECH MEDICAL, INC.	All Purpose Cuff	2021-10-22
GUDID 10840935109839 SUNTECH MEDICAL, INC.	All Purpose Cuff	2021-10-22
GUDID 10840935109822 SUNTECH MEDICAL, INC.	All Purpose Cuff	2021-10-22
GUDID 10840935109815 SUNTECH MEDICAL, INC.	All Purpose Cuff	2021-10-22
GUDID 10840935109808 SUNTECH MEDICAL, INC.	All Purpose Cuff	2021-10-22
GUDID 10840935109785 SUNTECH MEDICAL, INC.	All Purpose Cuff	2021-10-22
GUDID 10840935109778 SUNTECH MEDICAL, INC.	All Purpose Cuff	2021-10-22
GUDID 10840935109761 SUNTECH MEDICAL, INC.	All Purpose Cuff	2021-10-22
GUDID 10840935109754 SUNTECH MEDICAL, INC.	All Purpose Cuff	2021-10-22
GUDID 10840935109747 SUNTECH MEDICAL, INC.	All Purpose Cuff	2021-10-22
GUDID 10840935109723 SUNTECH MEDICAL, INC.	All Purpose Cuff	2021-10-22
GUDID 10840935109716 SUNTECH MEDICAL, INC.	All Purpose Cuff	2021-10-22
GUDID 10840935109709 SUNTECH MEDICAL, INC.	All Purpose Cuff	2021-10-22
GUDID 01084093519792 SUNTECH MEDICAL, INC.	All Purpose Cuff	2021-10-22
GUDID 01084093519730 SUNTECH MEDICAL, INC.	All Purpose Cuff	2021-10-22
GUDID 10840935108405 SUNTECH MEDICAL, INC.	All Purpose Cuff	2021-08-06
GUDID 10840935107521 SUNTECH MEDICAL, INC.	Disposable cuff	2021-05-17
GUDID 10840935109693 SUNTECH MEDICAL, INC.	SunTech	2021-05-11
GUDID 10840935109655 SUNTECH MEDICAL, INC.	Oscar 2	2021-04-16
GUDID 10840935108740 SUNTECH MEDICAL, INC.	Microport	2021-04-07
GUDID 10840935109648 SUNTECH MEDICAL, INC.	SunTech	2021-03-22
GUDID 10840935109631 SUNTECH MEDICAL, INC.	SunTech	2021-03-22
GUDID 10840935109624 SUNTECH MEDICAL, INC.	SunTech 91-0143-00	2021-03-01
GUDID 10840935109600 SUNTECH MEDICAL, INC.	SunTech	2021-02-01
GUDID 10840935109594 SUNTECH MEDICAL, INC.	SunTech	2021-02-01
GUDID 10840935109587 SUNTECH MEDICAL, INC.	SunTech	2021-02-01
GUDID 10840935109570 SUNTECH MEDICAL, INC.	SunTech	2021-02-01
GUDID 10840935109563 SUNTECH MEDICAL, INC.	SunTech	2021-02-01
GUDID 10840935109556 SUNTECH MEDICAL, INC.	SunTech	2021-02-01
GUDID 10840935109549 SUNTECH MEDICAL, INC.	Orbit K	2021-01-08
GUDID 10840935109532 SUNTECH MEDICAL, INC.	Orbit K	2021-01-08
GUDID 10840935109525 SUNTECH MEDICAL, INC.	Orbit K	2021-01-08
GUDID 10840935109518 SUNTECH MEDICAL, INC.	Orbit K	2021-01-08
GUDID 10840935109501 SUNTECH MEDICAL, INC.	Orbit K	2021-01-08
GUDID 10840935109495 SUNTECH MEDICAL, INC.	Orbit K	2021-01-08
GUDID 10840935109471 SUNTECH MEDICAL, INC.	Orbit K	2021-01-08
GUDID 10840935109488 SUNTECH MEDICAL, INC.	Orbit K	2021-01-07
GUDID 10840935109464 SUNTECH MEDICAL, INC.	SunTech	2020-12-31
GUDID 20840935109423 SUNTECH MEDICAL, INC.	Disposable Cuff	2020-12-28
GUDID 20840935109416 SUNTECH MEDICAL, INC.	Disposable Cuff	2020-12-28
PMN K160439 | FLL SUNTECH MEDICAL, INC.	CT40 Vital Signs	2016-07-13
PMN K160439 | DXN SUNTECH MEDICAL, INC.	CT40 Vital Signs	2016-07-13
PMN K160439 | DQA SUNTECH MEDICAL, INC.	CT40 Vital Signs	2016-07-13
PMN K151520 | DXN SUNTECH MEDICAL, INC.	SunTech Oscar 2, 24-HR ABPM	2016-02-21
PMN K151520 | DXN SUNTECH MEDICAL, INC.	Oscar 2, Model 250	2016-02-21
PMN K151520 SunTech Medical, Inc.	Oscar 2	2016-02-19
PMN K122401 | DXN SUNTECH MEDICAL, INC.	Tango M2	2012-11-08
PMN K122401 SUNTECH MEDICAL, INC.	TANGO M2 BLOOD PRESSURE MONITOR	2012-11-02
PMN K080854 | DXQ SUNTECH MEDICAL, INC.	Disposable Cuff	2008-10-24
PMN K080854 SUNTECH MEDICAL, INC.	DISPOSABLE BLOOD PRESSURE CUFF, MODEL DC100	2008-10-20
PMN K070750 | DXN SUNTECH MEDICAL, INC.	247 BP Device	2007-11-13
PMN K070750 SUNTECH MEDICAL, INC.	247 BP DEVICE	2007-05-02
PMN K051904 | DXQ SUNTECH MEDICAL, INC.	ALL PURPOSE CUFF	2006-12-07
PMN K060820 SUNTECH MEDICAL, INC.	CYCLE BP MONITOR AND PULSE OXIMETER, MODEL 1060	2006-06-07
PMN K053209 SUNTECH MEDICAL, INC.	TANGO+ AUTOMATIC BLOOD PRESSURE AND OXYGEN SATURATION MEASUREMENT SYSTEM	2006-01-05
PMN K051904 SUNTECH MEDICAL, INC.	ALL PURPOSE CUFF, MODEL 222APC	2005-09-09
PMN K970629 | DXN SUNTECH MEDICAL, INC.	Tango	1992-06-24
PMN K060820 | MUD SUNTECH MEDICAL, INC.	Cycle	1992-06-24
PMN K060820 | DXN SUNTECH MEDICAL, INC.	Cycle	1992-06-24
PMN K053209 | DXN SUNTECH MEDICAL, INC.	Tango+	1992-06-24
PMN K010622 | DXN SUNTECH MEDICAL, INC.	PressureTrak, Model 222-B	1992-06-24
PMN K010622 | DXN SUNTECH MEDICAL, INC.	Pressure Trak	1992-06-24
PMN K010622 | DXN SUNTECH MEDICAL, INC.	Bravo, Model 222-B	1992-06-24
PMN K010622 | DXN SUNTECH MEDICAL, INC.	Bravo LA, Model 222-B	1992-06-24
PMN K003004 | DXN SUNTECH MEDICAL, INC.	Oscar 2	1992-06-24

Similar & Related FDA Registered Companies

• SUNTECH MEDICAL INSTRUMENTS, INC.

Related Finance Registrations

NCAGE Code	0UJE9	SUNTECH MEDICAL, INC.
CAGE Code	0UJE9	SUNTECH MEDICAL, INC.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092539839	Yantian,China (Mainland) -> Long Beach, California	CUFF	1040 CTN
202009237513	Yantian,China (Mainland) -> Los Angeles, California	CUFF	964 CTN
2020092242430	Yantian,China (Mainland) -> Long Beach, California	CUFF	1088 CTN
2020091943120	Yantian,China (Mainland) -> Long Beach, California	CUFF	1088 CTN
2020091519061	Yantian,China (Mainland) -> Los Angeles, California	CUFF	964 CTN
2020091062374	Yantian,China (Mainland) -> Los Angeles, California	CUFF	800 CTN
2020083161788	Yantian,China (Mainland) -> Los Angeles, California	CUFF	964 CTN
2020083176644	Yantian,China (Mainland) -> Los Angeles, California	CUFF	524 CTN