Raumedic

FDA Filings

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

FDA Registration(s)

• Registration Number: 3006946348
• FEI Number: 3006946348
• Name: Christopher Major
• Owner & Operator: RAUMEDIC
• Contact Address: Hermann-Staudinger-Str. 2 ; Helmbrechts DE-BY Bayern 95233 DE
• Official Correspondent:
  • Reiner Thiem
  • 049-9252-359-2782
• US Agent:
  • Christopher Major
  • RAUMEDIC Inc.
  • 828 9740460
  • 828 6848871
  • Christopher.Major@raumedic.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 235 Broadpointe Dr ; Mills River, NC 28759 US
• Establishment Type:
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

• Registration Number: 3006942548
• FEI Number: 3006942548
• Name: Christopher Major
• Owner & Operator: RAUMEDIC
• Contact Address: Hermann-Staudinger-Str. 2 ; Helmbrechts DE-BY Bayern 95233 DE
• Official Correspondent:
  • Reiner Thiem
  • 049-9252-359-2782
• US Agent:
  • Christopher Major
  • RAUMEDIC Inc.
  • 828 9740460
  • 828 6848871
  • Christopher.Major@raumedic.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 235 Broadpointe Dr ; Mills River, NC 28759 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

• Registration Number: 3012232668
• FEI Number: 3012232668
• Name: RAUMEDIC, Incorporated.
• Owner & Operator: RAUMEDIC
• Contact Address: Hermann-Staudinger-Str. 2 ; Helmbrechts DE-BY Bayern 95233 DE
• Official Correspondent:
  • Reiner Thiem
  • 049-9252-359-2782
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 235 Broadpointe Dr ; Mills River, NC 28759 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
LXG Christopher Major [RAUMEDIC]	Sorterra Microfluidic Kit	2019-08-22
PMN K171666 | GWM Christopher Major [RAUMEDIC]	MPR2 logO DATALOGGER	2017-08-01
PMN K130529 | GWM Christopher Major [RAUMEDIC]	RAUMEDIC-PTO-Monitoring-System	2013-11-13
PMN K130529 | GWM Christopher Major [RAUMEDIC]	RAUMEDIC-PTO-Monitoring-System	2013-11-13
PMN K120252 | GWM Christopher Major [RAUMEDIC]	RAUMEDIC? -ICP-TEMP-Monitoring-System	2012-04-18
PMN K120252 | GWM Christopher Major [RAUMEDIC]	RAUMEDIC? -ICP-TEMP-Monitoring-System	2012-04-18
PMN K112017 | GWM Christopher Major [RAUMEDIC]	RAUMEDIC? -ICP-Monitoring-System ventricular	2011-11-09
PMN K112017 | GWM Christopher Major [RAUMEDIC]	RAUMEDIC? -ICP-Monitoring-System ventricular	2011-11-09
PMN K103206 | GWM Christopher Major [RAUMEDIC]	RAUMEDIC-ICP-Monitoring-System	2011-04-06
PMN K103206 | GWM Christopher Major [RAUMEDIC]	RAUMEDIC-ICP-Monitoring-System	2011-04-06

Similar & Related FDA Registered Companies

• RAUMEDIC Inc.
• Raumedic AG