Bittium Biosignals L T D

FDA Filings

This page includes the latest FDA filings for Bittium Biosignals 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: 1000425315
• FEI Number: 1000425315
• Name: Rene van de Zande
• Owner & Operator: Bittium Biosignals Ltd.
• Contact Address: Pioneerinkatu 6 --; KUOPIO FI-IS Ita-Suomen laani 70800 FI
• Official Correspondent:
  • ARTO - REMES
  • 358-175-817700-x
• US Agent:
  • Rene van de Zande
  • Emergo Global Representation LLC
  • 512 3279997
  • 512 3279998
  • USAgent@ul.com
• Importing Logistics Registration:
  • Importer: Bittium USA, Inc.
  • Address: 22722 29th Drive SE, Suite 100 ; Bothell, WA 98021 UNITED STATES
  • Importer Type: Agent
• Importing Logistics Registration:
  • Importer: Heart Care Consultants, LLC
  • Address: 5600 Chestnut Street ; Philadelphia, PA 19139 UNITED STATES
  • Importer Type: End User
• Importing Logistics Registration:
  • Importer: S. Medical Services
  • Address: 99 Pond Avenue no. 414 ; Brookline, MA 02445 UNITED STATES
  • Importer Type: End User
• Importing Logistics Registration:
  • Importer: Woodway USA, Inc.
  • Address: W229 N591 Foster Ct. ; Waukesha, WI 53186 UNITED STATES
  • Importer Type: Agent
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2500 Bee Cave Road Bldg 1, Suite 300; Austin, TX 78746 US
• Establishment Type:
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
PMN K182030 | MLO Rene van de Zande [Bittium Biosignals Ltd.]	Faros14d	2018-12-13
PMN K182030 | MLO Rene van de Zande [Bittium Biosignals Ltd.]	Faros Mobile	2018-12-13
PMN K182030 | MLO Rene van de Zande [Bittium Biosignals Ltd.]	Bittium Faros 360 waterproof	2018-12-13
PMN K182030 | MLO Rene van de Zande [Bittium Biosignals Ltd.]	Bittium Faros 180 waterproof	2018-12-13
PMN K182030 | MLO Rene van de Zande [Bittium Biosignals Ltd.]	Bittium Cardiac Navigator	2018-12-13
PMN K182030 | MLO Rene van de Zande [Bittium Biosignals Ltd.]	Bittium Cardiac Explorer	2018-12-13
PMN K182030 | DXH Rene van de Zande [Bittium Biosignals Ltd.]	Faros14d	2018-12-13
PMN K182030 | DXH Rene van de Zande [Bittium Biosignals Ltd.]	Faros Mobile	2018-12-13
PMN K182030 | DXH Rene van de Zande [Bittium Biosignals Ltd.]	Bittium Faros 360 waterproof	2018-12-13
PMN K182030 | DXH Rene van de Zande [Bittium Biosignals Ltd.]	Bittium Faros 180 waterproof	2018-12-13
PMN K182030 | DXH Rene van de Zande [Bittium Biosignals Ltd.]	Bittium Cardiac Navigator	2018-12-13
PMN K182030 | DXH Rene van de Zande [Bittium Biosignals Ltd.]	Bittium Cardiac Explorer	2018-12-13
PMN K182030 | DSI Rene van de Zande [Bittium Biosignals Ltd.]	Faros14d	2018-12-13
PMN K182030 | DSI Rene van de Zande [Bittium Biosignals Ltd.]	Faros Mobile	2018-12-13
PMN K182030 | DSI Rene van de Zande [Bittium Biosignals Ltd.]	Bittium Faros 360 waterproof	2018-12-13
PMN K182030 | DSI Rene van de Zande [Bittium Biosignals Ltd.]	Bittium Faros 180 waterproof	2018-12-13
PMN K182030 | DSI Rene van de Zande [Bittium Biosignals Ltd.]	Bittium Cardiac Navigator	2018-12-13
PMN K182030 | DSI Rene van de Zande [Bittium Biosignals Ltd.]	Bittium Cardiac Explorer	2018-12-13
PMN K182030 Bittium Biosignals Ltd.	Faros Mobile	2018-11-08
DRX Rene van de Zande [Bittium Biosignals Ltd.]	Fast-Fix ECG Electrode	2018-06-27
DRX Rene van de Zande [Bittium Biosignals Ltd.]	BodyGuardian MINI Strip	2018-06-27
PMN K143032 | DXH Rene van de Zande [Bittium Biosignals Ltd.]	eMotion Faros ECG Mobile	2015-04-02
PMN K143032 | DXH Rene van de Zande [Bittium Biosignals Ltd.]	eMotion Faros 90	2015-04-02
PMN K143032 | DXH Rene van de Zande [Bittium Biosignals Ltd.]	eMotion Faros 360	2015-04-02
PMN K143032 | DXH Rene van de Zande [Bittium Biosignals Ltd.]	eMotion Faros 180	2015-04-02
PMN K143032 | DXH Rene van de Zande [Bittium Biosignals Ltd.]	Virtual Clinic	2015-04-02
PMN K143032 | DXH Rene van de Zande [Bittium Biosignals Ltd.]	LiveECG	2015-04-02
PMN K131699 | DXH Rene van de Zande [Bittium Biosignals Ltd.]	eMotion ECG	2013-12-09
PMN K131699 | DXH Rene van de Zande [Bittium Biosignals Ltd.]	eMotion ECG Mobile	2013-12-09
PMN K131699 | DXH Rene van de Zande [Bittium Biosignals Ltd.]	LiveECG	2013-12-09
PMN K993411 | KPI Rene van de Zande [Bittium Biosignals Ltd.]	HOMETRAINER	2003-04-09
PMN K993411 | KPI Rene van de Zande [Bittium Biosignals Ltd.]	FEMISCAN:CLINIC SYSTEM	2003-04-09
PMN K993411 | KPI Rene van de Zande [Bittium Biosignals Ltd.]	CLINIC SET	2003-04-09
PMN K993411 | HIR Rene van de Zande [Bittium Biosignals Ltd.]	HOMETRAINER	2003-04-09
PMN K993411 | HIR Rene van de Zande [Bittium Biosignals Ltd.]	FEMISCAN:CLINIC SYSTEM	2003-04-09
PMN K993411 | HIR Rene van de Zande [Bittium Biosignals Ltd.]	CLINIC SET	2003-04-09
PMN K963202 | HCC Rene van de Zande [Bittium Biosignals Ltd.]	MUSCLE TRAINER	2003-04-09
PMN K963202 | HCC Rene van de Zande [Bittium Biosignals Ltd.]	ME6000	2003-04-09
PMN K963202 | HCC Rene van de Zande [Bittium Biosignals Ltd.]	ME3000P	2003-04-09