Brightway Holdings Sdn Bhd Plant 2

FDA Filings

This page includes the latest FDA filings for Brightway Holdings Sdn Bhd Plant 2. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3013546409
• FEI Number: 3013546409
• Name: BRIGHTWAY HOLDINGS SDN. BHD. (PLANT 2)
• Owner & Operator: BRIGHTWAY HOLDINGS SDN. BHD.
• Contact Address: LOT 1559, JALAN ISTIMEWA, BATU BELAH; KLANG, SELANGOR MY-NOTA 42100 MY
• Official Correspondent:
  • BASKARAN - GOVINDASAMY
  • 60-3-3431007-x
• US Agent:
  • Jerry Doane
  • 716 7750533
  • jdoane@usagent-tobias.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: PT4250 & PT4251, SOLOK SULTAN HISHAMUDDIN 7, KAW. 20, PELABUHAN KLANG UTARA K/U 17,; KLANG, SELANGOR Selangor, 42100 MY
• Establishment Type:
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K170686 | LZC BRIGHTWAY HOLDINGS SDN. BHD. (PLANT 2) [BRIGHTWAY HOLDINGS SDN. BHD.]	Brightway Holdings Sdn Bhd	2019-03-26
PMN K170686 | LZA BRIGHTWAY HOLDINGS SDN. BHD. (PLANT 2) [BRIGHTWAY HOLDINGS SDN. BHD.]	Brightway Holdings Sdn Bhd	2019-03-26
PMN K994281 | LZA BRIGHTWAY HOLDINGS SDN. BHD. (PLANT 2) [BRIGHTWAY HOLDINGS SDN. BHD.]	Kimberly-Clark Global Sales	2018-10-29
PMN K994281 | LZA BRIGHTWAY HOLDINGS SDN. BHD. (PLANT 2) [BRIGHTWAY HOLDINGS SDN. BHD.]	Brightway Holdings Sdn Bhd	2018-10-29
PMN K163267 | LZA BRIGHTWAY HOLDINGS SDN. BHD. (PLANT 2) [BRIGHTWAY HOLDINGS SDN. BHD.]	Brightway Nitrile Examination Glove, Powder Free (Blue)	2017-06-06
PMN K162294 | LZC BRIGHTWAY HOLDINGS SDN. BHD. (PLANT 2) [BRIGHTWAY HOLDINGS SDN. BHD.]	Brightway Brand Nitrile Examination Gloves 12" Powder Free, Purple Tested for use with Chemotherapy Drugs	2017-06-06
PMN K162294 | LZA BRIGHTWAY HOLDINGS SDN. BHD. (PLANT 2) [BRIGHTWAY HOLDINGS SDN. BHD.]	Brightway Brand Nitrile Examination Gloves 12" Powder Free, Purple Tested for use with Chemotherapy Drugs	2017-06-06
PMN K162186 | LZC BRIGHTWAY HOLDINGS SDN. BHD. (PLANT 2) [BRIGHTWAY HOLDINGS SDN. BHD.]	Brightway Brand Nitrile Examination Gloves 12", Powder Free, (Sterling/Grey) Tested for use with Chemotherapy Drugs	2017-06-06
PMN K162146 | LZA BRIGHTWAY HOLDINGS SDN. BHD. (PLANT 2) [BRIGHTWAY HOLDINGS SDN. BHD.]	BrightwayBrand Nitrile Examination Gloves, Powder Free (Lavender)	2017-06-06
PMN K161215 | LZC BRIGHTWAY HOLDINGS SDN. BHD. (PLANT 2) [BRIGHTWAY HOLDINGS SDN. BHD.]	BrightwayBrand Nitrile Examination Gloves 10", Powder Free (Sterling/Grey) - Tested for use with Chemotherapy Drugs	2017-06-06
PMN K161215 | LZA BRIGHTWAY HOLDINGS SDN. BHD. (PLANT 2) [BRIGHTWAY HOLDINGS SDN. BHD.]	BrightwayBrand Nitrile Examination Gloves 10", Powder Free (Sterling/Grey) - Tested for use with Chemotherapy Drugs	2017-06-06
PMN K992021 | KGO BRIGHTWAY HOLDINGS SDN. BHD. (PLANT 2) [BRIGHTWAY HOLDINGS SDN. BHD.]	BRIGHTWAY BRAND	2007-12-14
PMN K991939 | KGO BRIGHTWAY HOLDINGS SDN. BHD. (PLANT 2) [BRIGHTWAY HOLDINGS SDN. BHD.]	BRIGHTWAY BRAND	2007-12-14
PMN K990878 | LZA BRIGHTWAY HOLDINGS SDN. BHD. (PLANT 2) [BRIGHTWAY HOLDINGS SDN. BHD.]	BRIGHTWAY BRAND	2007-12-14
PMN K990540 | LYY BRIGHTWAY HOLDINGS SDN. BHD. (PLANT 2) [BRIGHTWAY HOLDINGS SDN. BHD.]	BRIGHTWAY BRAND	2007-12-14
PMN K990539 | LYY BRIGHTWAY HOLDINGS SDN. BHD. (PLANT 2) [BRIGHTWAY HOLDINGS SDN. BHD.]	BRIGHTWAY BRAND	2007-12-14
PMN K060402 | LZA BRIGHTWAY HOLDINGS SDN. BHD. (PLANT 2) [BRIGHTWAY HOLDINGS SDN. BHD.]	BRIGHTWAY BRAND	2007-12-14
PMN K022878 | LZA BRIGHTWAY HOLDINGS SDN. BHD. (PLANT 2) [BRIGHTWAY HOLDINGS SDN. BHD.]	BRIGHTWAY BRAND	2007-12-14