Temec Technologies B V

FDA Filings

This page includes the latest FDA filings for Temec Technologies 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: 3006850235
• FEI Number: 3006850235
• Name: Temec Technologies B.V.
• Owner & Operator: Temec Technologies B.V.
• Contact Address: Sourethweg 5J ; HEERLEN NL-LI Limburg 6422 PC NL
• Official Correspondent:
  • Yaacov Bar Lev
  • 31-45-7370303-x
• US Agent:
  • Daniel Kamm
  • Kamm & Associates
  • 239 4171727
  • fda.help.now@gmail.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Sourethweg 5J ; HEERLEN Limburg, 6422 PC NL
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K000338 | OLV Temec Technologies B.V.	Full-montage Standard Electroencephalograph, Standard polysomnograph with electroencephalograph	2015-05-26
PMN K000338 | GWQ Temec Technologies B.V.	Full-montage Standard Electroencephalograph, Standard polysomnograph with electroencephalograph	2015-05-26
PMN K072014 | MNR Temec Technologies B.V.	VENTILATORY EFFORT RECORDER	2007-12-17