Schwarzer Cardiotek G M B H

FDA Filings

This page includes the latest FDA filings for Schwarzer Cardiotek G M B H. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3008329188
• FEI Number: 3008329188
• Name: CARDIOTEK BV
• Owner & Operator: Schwarzer Cardiotek GmbH
• Contact Address: Im Zukunftspark 3 ; Heilbronn DE-NOTA 74076 DE
• Official Correspondent:
  • Tatjana Nuber
  • 49-7131-2774-500
• US Agent:
  • Melissa Walker
  • Graematter, Inc.
  • 636 4057498
  • 702 9208509
  • mwalker@graematter.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Dr. Nolenslaan 107B ; GL SIttard Limburg, 6136 NL
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K183266 | DQK CARDIOTEK BV [Schwarzer Cardiotek GmbH]	EP-TRACER	2019-07-01
PMN K183266 Schwarzer CardioTek GmbH	EP-TRACER System	2019-03-01
PMN K161245 | DQK CARDIOTEK BV [Schwarzer Cardiotek GmbH]	EP-Tracer System	2018-12-04
PMN K134044 | DQK CARDIOTEK BV [Schwarzer Cardiotek GmbH]	EP Tracer	2015-02-17

Related Finance Registrations

NCAGE Code

CN4M2

SCHWARZER CARDIOTEK GMBH