Sagami Manufacturers Sdn Bhd Ipoh Factory

FDA Filings

This page includes the latest FDA filings for Sagami Manufacturers Sdn Bhd Ipoh Factory. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3005191252
• FEI Number: 3005191252
• Name: SAGAMI MANUFACTURERS SDN. BHD. IPOH FACTORY
• Owner & Operator: SAGAMI MANUFACTURERS SDN. BHD. IPOH FACTORY
• Contact Address: 2, JALAN KILANG TIGA JELAPANG LIGHT IND. ESTATE; IPOH MY-08 Perak 30100 MY
• Official Correspondent:
  • MEI LEE - CHING
  • 60-5-5262254-x
• US Agent:
  • Richard Hettenbach
  • 973 2147468
  • 973 9938047
  • Rhettenbach@Medqra.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2, JALAN KILANG TIGA JELAPANG LIGHT IND. ESTATE; IPOH Perak, 30100 MY
• Establishment Type: Repack or Relabel Medical Device

FDA Filings

Device Company	Device	Date
PMN K113686 | HIS SAGAMI MANUFACTURERS SDN. BHD. IPOH FACTORY	Reality Ultra Lubricated	2012-10-31
PMN K113686 | HIS SAGAMI MANUFACTURERS SDN. BHD. IPOH FACTORY	Kimono MicroThin with Aqua Lube	2012-10-31
PMN K946376 | HIS SAGAMI MANUFACTURERS SDN. BHD. IPOH FACTORY	Kimono	2008-03-24
PMN K946374 | HIS SAGAMI MANUFACTURERS SDN. BHD. IPOH FACTORY	Kimono	2008-03-24
PMN K897129 | HIS SAGAMI MANUFACTURERS SDN. BHD. IPOH FACTORY	Kimono	2008-03-24