Unitron Group B V

FDA Filings

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

FDA Registration(s)

• Registration Number: 3008388260
• FEI Number: 3008388260
• Name: UNITRON GROUP BV
• Owner & Operator: Unitron Group BV
• Contact Address: Schansestraat 7 ; IJzendijke NL-ZE Zeeland 4515 RN NL
• Official Correspondent:
  • Manon de Koeijer
  • 31-117-307300-x
• US Agent:
  • Jennifer Hadfield
  • Qserve Group US, Inc.
  • 603 3693550
  • jennifer.hadfield@qservegroup.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Schansestraat 7 ; IJzendijke Zeeland, 4515 RN NL
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K180608 | MYB UNITRON GROUP BV	Lunoa SPT	2018-11-05
PMN K003020 | DXO UNITRON GROUP BV	Inca	2010-05-12
PMN K003020 | DRQ UNITRON GROUP BV	Inca	2010-05-12
PMN K003020 | DQO UNITRON GROUP BV	Inca	2010-05-12
EKM UNITRON GROUP BV	Thermaprep Plus Obturator Oven	2010-05-12
EKM UNITRON GROUP BV	Thermaprep 2 Obturator Oven	2010-05-12
EKM UNITRON GROUP BV	Protaper Universal Obturator Oven	2010-05-12
EKM UNITRON GROUP BV	Profile Vortex Obturator Oven	2010-05-12
EKM UNITRON GROUP BV	Guttamaster Obturator Oven	2010-05-12
EKM UNITRON GROUP BV	GT Series X Obturator Oven	2010-05-12
EKM UNITRON GROUP BV	GT Obturator Obturator Oven	2010-05-12