Unip Berhad

FDA Filings

This page includes the latest FDA filings for Unip Berhad. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3003361112
• FEI Number: 3003361112
• Name: UNIP PLASTIC INDUSTRIES SDN BHD
• Owner & Operator: Unip Berhad
• Contact Address: Lot 3, Jalan CJ1/6, Kawasan Perusahaan Cheras Jaya, Jalan Balakong, Batu 11,; Cheras, MY-10 Selangor 43200 MY
• Official Correspondent:
  • MoiKwee - Choong
  • 60-3-90742451-0
• US Agent:
  • Bryan Tapocik
  • IPB Inc
  • 909 8647477 1000
  • 909 8647232
  • rosanne@ipbinc.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: LOT 3, JALAN CJ 1/6, KAWASAN PERUSAHAAN CHERAS JAYA, JALAN BALAKONG, BATU 11,; CHERAS Selangor, 43200 MY
• Establishment Type:
  • Repack or Relabel Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

• Registration Number: 3003940985
• FEI Number: 3003940985
• Name: SINORITA SENDIRIAN BERHAD
• Owner & Operator: Unip Berhad
• Contact Address: Lot 3, Jalan CJ1/6, Kawasan Perusahaan Cheras Jaya, Jalan Balakong, Batu 11,; Cheras, MY-10 Selangor 43200 MY
• Official Correspondent:
  • MoiKwee - Choong
  • 60-3-90742451-0
• US Agent:
  • Bryan Tapocik
  • IPB Inc
  • 909 8647477 1000
  • 909 8647232
  • rosanne@ipbinc.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: LOT 45, JALAN CJ 1/6, KAWASAN PERUSAHAAN CHERAS JAYA JALAN BALAKONG, BATU 11; CHERAS Selangor, 43200 MY
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
EKA UNIP PLASTIC INDUSTRIES SDN BHD [Unip Berhad]	STRIP	2016-09-02
PMN K140685 | NYL UNIP PLASTIC INDUSTRIES SDN BHD [Unip Berhad]	HANDPIECE, AIR-POWERED, ROOT CANAL IRRIGATION	2014-09-03
KXF UNIP PLASTIC INDUSTRIES SDN BHD [Unip Berhad]	APPLICATOR	2014-06-20
EHY UNIP PLASTIC INDUSTRIES SDN BHD [Unip Berhad]	IMPRESSION TRAY	2014-03-24
LCN UNIP PLASTIC INDUSTRIES SDN BHD [Unip Berhad]	TONGUE SCRAPER	2013-11-04
GDY UNIP PLASTIC INDUSTRIES SDN BHD [Unip Berhad]	ZOOM CH GAUZE 12PK	2005-08-19
GDY UNIP PLASTIC INDUSTRIES SDN BHD [Unip Berhad]	GAUZE	2005-08-19
EFW SINORITA SENDIRIAN BERHAD [Unip Berhad]	MANUAL DENTAL	2004-08-06
EGD UNIP PLASTIC INDUSTRIES SDN BHD [Unip Berhad]	WAX	2004-06-02