Hunan Accurate Bio Medical Technology Co L T D

FDA Filings

This page includes the latest FDA filings for Hunan Accurate Bio Medical Technology 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: 3011353016
• FEI Number: 3011353016
• Name: DENNIS XU
• Owner & Operator: Hunan Accurate Bio-Medical Technology Co., Ltd.
• Contact Address: 6th,Floor,Biyang Industrial Zone, Lijiac 410208 Changsha,Hunan Province,China; Changsha CN-43 Hunan 410208 CN
• Official Correspondent:
  • Li Zhang
  • 86-731-84118539-x
• US Agent:
  • DENNIS XU
  • PERFORMANCE INTERNATIOANL, CORP
  • 919 8590478
  • ybx99@yahoo.com
• Importing Logistics Registration:
  • Importer: S&W TREND
  • Address: 104 WILSON AVE APT 4 PASADENA,CA 91106 ; Pasadena, CA 91106 UNITED STATES
• Importing Logistics Registration:
  • Importer: Shenzhen Lingshang E-commerce Co., Ltd.
  • Address: Liuxianju Building 4, 703 Nanshan District Xili Street ; Shenzhen, 518000 CHINA
  • Subdivision: CN-44
• Importing Logistics Registration:
  • Importer: Thousandshores Inc.
  • Address: 33442 Western Avenue ; ,
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 4004 PEPPERTON ; Raleigh, NC 27606 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 06927394502474 Hunan Accurate Bio-Medical Technology Co., Ltd.	CONCORD	2024-10-21
GUDID 06927394500999 Hunan Accurate Bio-Medical Technology Co., Ltd.	Accare®	2023-11-14
GUDID 06927394511162 Hunan Accurate Bio-Medical Technology Co., Ltd.	Accurate®	2023-03-21
GUDID 06927394511148 Hunan Accurate Bio-Medical Technology Co., Ltd.	Accurate®	2023-03-21
GUDID 06927394511131 Hunan Accurate Bio-Medical Technology Co., Ltd.	Accurate®	2023-03-21
GUDID 06927394511124 Hunan Accurate Bio-Medical Technology Co., Ltd.	Accurate®	2023-03-21
GUDID 06927394511117 Hunan Accurate Bio-Medical Technology Co., Ltd.	Accurate®	2023-03-21
GUDID 06927394511100 Hunan Accurate Bio-Medical Technology Co., Ltd.	Accurate®	2023-03-21
GUDID 06927394501606 Hunan Accurate Bio-Medical Technology Co., Ltd.	Accurate®	2023-03-21
GUDID 06927394501590 Hunan Accurate Bio-Medical Technology Co., Ltd.	Accurate®	2023-03-21
GUDID 06927394501583 Hunan Accurate Bio-Medical Technology Co., Ltd.	Accurate®	2023-03-21
GUDID 06927394511179 Hunan Accurate Bio-Medical Technology Co., Ltd.	Accurate®	2023-03-20
GUDID 06927394500180 Hunan Accurate Bio-Medical Technology Co., Ltd.	CONCORD	2021-09-06
GUDID 06927394500104 Hunan Accurate Bio-Medical Technology Co., Ltd.	CONCORD	2021-03-22
GUDID 06927394535557 Hunan Accurate Bio-Medical Technology Co., Ltd.	CONCORD	2019-10-08
GUDID 06927394533348 Hunan Accurate Bio-Medical Technology Co., Ltd.	Accurate®	2019-09-18
GUDID 06927394555555 Hunan Accurate Bio-Medical Technology Co., Ltd.	Accurate®	2018-12-31
GUDID 06927394544443 Hunan Accurate Bio-Medical Technology Co., Ltd.	Accurate®	2018-12-31
GUDID 06927394533331 Hunan Accurate Bio-Medical Technology Co., Ltd.	Accurate®	2018-12-31
GUDID 06927394500081 Hunan Accurate Bio-Medical Technology Co., Ltd.	Accurate®	2018-12-31
GUDID 06927394500074 Hunan Accurate Bio-Medical Technology Co., Ltd.	Accurate®	2018-12-31
GUDID 06927394500067 Hunan Accurate Bio-Medical Technology Co., Ltd.	Accurate®	2018-12-31
GUDID 06927394500050 Hunan Accurate Bio-Medical Technology Co., Ltd.	Accurate®	2018-12-31
GUDID 06927394500036 Hunan Accurate Bio-Medical Technology Co., Ltd.	Accurate®	2018-12-31
GUDID 06927394500029 Hunan Accurate Bio-Medical Technology Co., Ltd.	Accurate®	2018-12-31
GUDID 06927394500012 Hunan Accurate Bio-Medical Technology Co., Ltd.	Accurate®	2018-12-31
GUDID 06927394500005 Hunan Accurate Bio-Medical Technology Co., Ltd.	Accurate®	2018-12-31
GUDID 69273945000814 Hunan Accurate Bio-Medical Technology Co., Ltd.	Accurate®	2018-08-17
GUDID 69273945000746 Hunan Accurate Bio-Medical Technology Co., Ltd.	Accurate®	2018-08-17
GUDID 69273945000128 Hunan Accurate Bio-Medical Technology Co., Ltd.	Accurate®	2018-08-17
GUDID 69273945000050 Hunan Accurate Bio-Medical Technology Co., Ltd.	Accurate®	2018-08-17
GUDID 69273945555550 Hunan Accurate Bio-Medical Technology Co., Ltd.	Accurate	2018-07-06
GUDID 69273945000500 Hunan Accurate Bio-Medical Technology Co., Ltd.	Accurate	2018-07-06
GUDID 00370393908017 Hunan Accurate Bio-Medical Technology Co., Ltd.	CareTouch	2018-07-06
PMN K171241 | DQA DENNIS XU [Hunan Accurate Bio-Medical Technology Co., Ltd.]	Pulse oximeter HS10A	2018-04-10
PMN K171241 Hunan Accurate Bio-Medical Technology Co., Ltd.	Pulse Oximeter	2018-03-27
OCH DENNIS XU [Hunan Accurate Bio-Medical Technology Co., Ltd.]	Pulse oximeter	2015-01-04
OCH DENNIS XU [Hunan Accurate Bio-Medical Technology Co., Ltd.]	Pulse Oximeter FS10F and FS20F;Pulse Oximeter FS10I;Pulse Oximeter FS10K and FS20K;Pulse Oximeter FS10P;	2015-01-04
OCH DENNIS XU [Hunan Accurate Bio-Medical Technology Co., Ltd.]	FS10A,FS20A,FS10C,FS20C,FS10D,FS20D,FS10E,FS20E,HS10A,HS20A,	2015-01-04
PMN K141105 | DQA DENNIS XU [Hunan Accurate Bio-Medical Technology Co., Ltd.]	Pulse Oximeter; Pulse Oximeter FS10C and FS20C; Pulse Oximeter FS10D and FS20D	2014-12-16
PMN K141105 | DQA DENNIS XU [Hunan Accurate Bio-Medical Technology Co., Ltd.]	Pulse Oximeter FS10F and FS20F;Pulse Oximeter FS10I;Pulse Oximeter FS10K and FS20K;Pulse Oximeter FS10P;	2014-12-16
PMN K141105 | DQA DENNIS XU [Hunan Accurate Bio-Medical Technology Co., Ltd.]	Pulse Oximeter FS10E and FS20E	2014-12-16
PMN K141105 HUNAN ACCURATE BIO-MEDICAL TECHNOLOGY CO., LTD.	PULSE OXIMETER	2014-12-04