Shenzhen Carewell Electronics Co L T D

FDA Filings

This page includes the latest FDA filings for Shenzhen Carewell Electronics 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: 3010089768
• FEI Number: 3010089768
• Name: SHENZHEN CAREWELL ELECTRONICS CO., LTD.
• Owner & Operator: Shenzhen Carewell Electronics Co., Ltd.
• Contact Address: Floor 4, BLD 9, Baiwangxin High-Tech Ind Nanshan District 518108,Shenzhen, P.R. C; Shenzhen CN-44 Guangdong 518108 CN
• Official Correspondent:
  • Minhong Gao
  • 86-755-86170389-8070
• US Agent:
  • Macro Mu
  • MID-LINK INTERNATIONAL CO., Ltd
  • 360 3257028
  • us.agent@mid-link.net
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Floor 4, BLD 9, Baiwangxin High-Tech Industrial Park, Songbai Ro Nanshan District; Shenzhen Guangdong, 518108 CN
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K200036 Shenzhen Carewell Electronics Co., Ltd.	AI-ECG Tracker	2020-03-20
GUDID 06971049340706 Shenzhen Carewell Electronics Co., Ltd.	Carewell	2020-02-10
GUDID 06971049340690 Shenzhen Carewell Electronics Co., Ltd.	Carewell	2020-02-10
GUDID 06971049340683 Shenzhen Carewell Electronics Co., Ltd.	Carewell	2020-02-10
GUDID 06971049340676 Shenzhen Carewell Electronics Co., Ltd.	Carewell	2020-02-10
GUDID 06971049340669 Shenzhen Carewell Electronics Co., Ltd.	Carewell	2020-02-10
GUDID 06971049340652 Shenzhen Carewell Electronics Co., Ltd.	Carewell	2020-02-10
PMN K113485 SHENZHEN CAREWELL ELECTRONICS CO., LTD	ELECTROCARDIOGRAPH	2012-04-25