Sentienx Sdn Bhd

FDA Filings

This page includes the latest FDA filings for Sentienx 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 Number3011580969
FEI Number3011580969
NameSENTIENX SDN BHD
Owner & OperatorSentienx Sdn Bhd
Contact Address1, Jalan Hi-Tech 12
Kulim MY-02 Kedah 09000 MY
Official Correspondent
  • Calvin Ng Soon Ghee
  • 60-44-019888-x
US Agent
  • David Lim
  • 626 9697838 108
  • 626 9697823
  • Limdavid33@Gmail.com
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressLot 7, Jalan Hi-Tech 12, Zon Industri Fasa 3, Kulim Hi-Tech Park
Kulim Kedah, 09090 MY
Establishment Type
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Manufacture Medical Device

FDA Filings

Device
Company
DeviceDate
SENTIENX SDN BHD
Finessis Zero Flexylon Powder Free Sterile White Surgical Glove Tested for use with Chemotherapy Drugs2018-06-07
SENTIENX SDN BHD
Finessis Zero Flexylon Powder Free Sterile White Surgical Glove2018-06-07
SENTIENX SDN BHD
Finessis Zero Chemo Flexylon Powder Free Sterile White Surgical Glove2018-06-07
SENTIENX SDN BHD
FINESSIS VIOLET ELEMENT POLYISOPRENE POWDERFREE STERILE SURGICAL GLOVES2018-06-07
SENTIENX SDN BHD
FINESSIS POLYISOPRENE POWDERFREE SURGICAL GLOVES2018-06-07
SENTIENX SDN BHD
Finessis Personal2017-12-19
SENTIENX SDN BHD
Finessis Zero Flexylon Powder Free Sterile White Surgical Glove2015-11-16
SENTIENX SDN BHD
Finessis Corium Flexylon Powder Free Sterile Green Surgical Gloves. Microsurgery and Underglove2015-11-16
SENTIENX SDN BHD
G-DERM POWDER-FREE SYNTHETIC SURGICAL GLOVE2015-11-04
SENTIENX SDN BHD
Nuzone X32015-09-02
SENTIENX SDN BHD
Sensiflex Plus2015-09-02
SENTIENX SDN BHD
Nuzone X2T Chemo2015-09-02
SENTIENX SDN BHD
Maxitex2015-09-02
SENTIENX SDN BHD
Fusion2015-09-02

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092220352Singapore,Singapore -> Los Angeles, CaliforniaGLOVES2100 CAS
202009183186Port Swettenham,Malaysia -> Los Angeles, CaliforniaGLOVES2100 CAS
202009126043Port Swettenham,Malaysia -> Los Angeles, CaliforniaGLOVES2100 CAS
202009106812Port Swettenham,Malaysia -> Los Angeles, CaliforniaGLOVES2100 CAS
202009083572Port Swettenham,Malaysia -> Los Angeles, CaliforniaGLOVES2100 CAS
2020090315113Port Swettenham,Malaysia -> Los Angeles, CaliforniaGLOVES2100 CAS
2020090215920Port Swettenham,Malaysia -> Los Angeles, CaliforniaGLOVES2100 CAS
2020082820450Port Swettenham,Malaysia -> Los Angeles, CaliforniaGLOVES2100 CAS
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