Karex Industries Sdn Bhd

FDA Filings

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

MALAYSIABURSA MALAYSIA5247DUNS 652280256
FDA Registration(s)
Registration Number9680135
FEI Number1000535235
NameKAREX INDUSTRIES SDN BHD
Owner & OperatorKAREX INDUSTRIES SDN BHD
Contact AddressPTD. 7906/7907, Taman Pontian Jaya BT. 34, Jalan Johor
Pontian MY-01 Johor 82000 MY
Official Correspondent
  • Leng Kian - Goh
  • 60-07-6881996-28
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressPTD. 7906/7907, TAMAN PONTIAN JAYA BT. 34, JALAN JOHOR
PONTIAN Johor, 82000 MY
Establishment Type
  • Manufacture Medical Device
  • Repack or Relabel Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device
Company
DeviceDate
KAREX INDUSTRIES SDN. BHD.
Water Based Personal Lubricant With Flavours2015-11-12
KAREX INDUSTRIES SDN BHD
NATURAL RUBBER LATEX MALE CONDOMS2014-08-01
KAREX INDUSTRIES SDN BHD
BLACK COLOURED CONDOM2013-11-25
KAREX INDUSTRIES SDN BHD
ORANGE COLORED CONDOMS ORANGE SCENT2012-07-03
KAREX INDUSTRIES SDN BHD.
LARGE/EXTRA LAGRE CONDOM2011-12-07
KAREX INDUSTRIES SDN BHD
KAREX INDUSTRIES MALE NATURAL RUBBER LATEX CONDOM, NON-SPERMICIDAL, LUBRICATED AND NON LUBRICATED2009-02-06
KAREX INDUSTRIES SDN BHD
MALE NATURAL RUBBER LATEX CONDOM (WITH COLORING AND FLAVORING)2007-05-08

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
202009219701Tanjung Pelepas,Malaysia -> Seattle, WashingtonLATEX CONDOMS4348 CTN
202009144510Tanjung Pelepas,Malaysia -> Seattle, WashingtonLATEX CONDOMS3404 CTN
2020091443750Tanjung Pelepas,Malaysia -> New York/Newark Area, Newark, New JerseyCONDOMS2096 CTN
2020091437003Tanjung Pelepas,Malaysia -> New York/Newark Area, Newark, New JerseyCONDOMS3800 CTN
202009074232Tanjung Pelepas,Malaysia -> New York/Newark Area, Newark, New JerseyCONDOMS2000 CTN
202009074244Tanjung Pelepas,Malaysia -> New York/Newark Area, Newark, New JerseyCONDOMS7000 CTN
202009074218Tanjung Pelepas,Malaysia -> New York/Newark Area, Newark, New JerseyCONDOMS355 CTN
202009052032Laem Chabang,Thailand -> Seattle, WashingtonLATEX CONDOMS3804 CTN
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