Pharmasept L T D Medical Products

FDA Filings

This page includes the latest FDA filings for Pharmasept L T D Medical Products. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3003623887
• FEI Number: 3003623887
• Name: PHARMASEPT LTD. MEDICAL PRODUCTS
• Owner & Operator: PHARMASEPT LTD. MEDICAL PRODUCTS
• Contact Address: 9 Shaham St. Northern Industrial Park; Caesarea IL-NOTA 3088900 IL
• US Agent:
  • Kevin Walls
  • Regulatory Insight, Inc.
  • 720 9625412
  • 720 9625413
  • kevin@reginsight.com
• Importing Logistics Registration:
  • Importer: MedXPress.pro
  • Address: Janseniusstraat 62 ; Leuven, 3000 BELGIUM
  • Subdivision: BE-NOTA
• Importing Logistics Registration:
  • Importer: Safersonic US, Inc.
  • Address: 2873 Arlington AV Suite 110 ; Highland Park, IL 60035 UNITED STATES
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 9 Shaham St. Northern Industrial Park; Caesarea, 3088900 IL
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K092858 | ITX PHARMASEPT LTD. MEDICAL PRODUCTS	Time Out Ultrasound Probe Cover	2016-11-30
PMN K092858 | ITX PHARMASEPT LTD. MEDICAL PRODUCTS	Safersonic? Sonography Cover	2016-11-30
PMN K092858 | ITX PHARMASEPT LTD. MEDICAL PRODUCTS	S11104 - Pajunk Labeled Safersonic Conti	2016-11-30
PMN K092858 | ITX PHARMASEPT LTD. MEDICAL PRODUCTS	S11103 - Pajunk Labeled Safersonic Single	2016-11-30
PMN K092858 | ITX PHARMASEPT LTD. MEDICAL PRODUCTS	S11102 - Pajunk Labeled Safersonic Conti with Gel	2016-11-30
PMN K092858 | ITX PHARMASEPT LTD. MEDICAL PRODUCTS	S11101 - Pajunk Labeled Safersonic Single with Gel	2016-11-30
PMN K092858 | ITX PHARMASEPT LTD. MEDICAL PRODUCTS	DAN-33512NWG - Safersonic Conti Narrow with Gel	2016-11-30
PMN K092858 | ITX PHARMASEPT LTD. MEDICAL PRODUCTS	DAN-33505NWG - Safersonic Medium Narrow with Gel	2016-11-30
KQM PHARMASEPT LTD. MEDICAL PRODUCTS	DAN-33825WG Long with Gel	2001-04-20
KQM PHARMASEPT LTD. MEDICAL PRODUCTS	DAN-33825 Long	2001-04-20
KQM PHARMASEPT LTD. MEDICAL PRODUCTS	DAN-33812U Conti Non Sterile	2001-04-20
KQM PHARMASEPT LTD. MEDICAL PRODUCTS	DAN-33812-WG Conti Plus	2001-04-20
KQM PHARMASEPT LTD. MEDICAL PRODUCTS	DAN-33812 Conti	2001-04-20
KQM PHARMASEPT LTD. MEDICAL PRODUCTS	DAN-33805U Medium Non Sterile	2001-04-20
KQM PHARMASEPT LTD. MEDICAL PRODUCTS	DAN-33805-WG Medium Plus	2001-04-20
KQM PHARMASEPT LTD. MEDICAL PRODUCTS	DAN-33805 Medium	2001-04-20
KQM PHARMASEPT LTD. MEDICAL PRODUCTS	DAN-33803U Single Non Sterile	2001-04-20
KQM PHARMASEPT LTD. MEDICAL PRODUCTS	DAN-33803-WG Single Plus	2001-04-20
KQM PHARMASEPT LTD. MEDICAL PRODUCTS	DAN-33803-NT Single - No Tape	2001-04-20
KQM PHARMASEPT LTD. MEDICAL PRODUCTS	DAN-33803 Single	2001-04-20
HRM PHARMASEPT LTD. MEDICAL PRODUCTS	PSC Florida	2001-04-20