Wear Safe Malaysia Sdn Bhd Facility Ii

FDA Filings

This page includes the latest FDA filings for Wear Safe Malaysia Sdn Bhd Facility Ii. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3010195579
• FEI Number: 3010195579
• Name: WEAR SAFE (MALAYSIA) SDN. BHD.-FACILITY II
• Owner & Operator: WEAR SAFE (MALAYSIA) SDN. BHD.-FACILITY II
• Contact Address: LOT 63616, PT 54924, NO 3, Jalan Korporat 7C/KU9,Taman Perindustrian Meru; Mukim Kapar, Klang MY-10 Selangor 42200 MY
• Official Correspondent:
  • LIM SIEW BING
  • 60-3-33936088-x
• US Agent:
  • HAI WANG
  • Parexel International
  • 301 6345515
  • 301 6348040
  • Hai.Wang@parexel.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: LOT 63616, PT 54924, NO 3, Jalan Korporat 7C/KU9 Taman Perindustrian Meru, Mukim Kapar,; Klang Selangor, 42200 MY
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K123469 WEAR SAFE (MALAYSIA) SDN BHD - FACILITY II	POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE AND WHITE COLORED, NON-STERILE	2013-02-19