Medical Latex Dua Sdn Bhd

FDA Filings

This page includes the latest FDA filings for Medical Latex Dua Sdn Bhd. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3010263795
• FEI Number: 3010263795
• Name: Davin Wedel
• Owner & Operator: Medical-Latex (DUA) SDN BHD
• Contact Address: Plo 8 Senai Industrial Estate Senai; Johor MY-01 Johor 81400 MY
• Official Correspondent:
  • Sharene Ang
  • 60-07-5978-100
• US Agent:
  • Davin Wedel
  • Global Protection Corp.
  • 617 9462800
  • davin@globalprotection.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 12 Channel Street ; Boston, MA 02210 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K120555 | HIS Davin Wedel [Medical-Latex (DUA) SDN BHD]	ESP	2013-06-26
PMN K120555 MEDICAL-LATEX (DUA) SDN. BHD	LATEX MALE CONDOM (SMOOTH SURFACE) LATEX MALE CONDOM (TEXTURED SURFACE)	2012-11-02