Careplus M Sdn Bhd

FDA Filings

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

MALAYSIABURSA MALAYSIA0163DUNS 652436312
FDA Registration(s)
Registration Number3010436932
FEI Number3010436932
NameMANOJ ZACHARIAS
Owner & OperatorCareplus (M) Sdn Bhd
Contact AddressLot 120 & 121, Jalan Senawang 3 Senawang Industrial Estate
Seremban MY-05 Negeri Sembilan 70450 MY
Official Correspondent
  • Lim Kwee Shyan
  • 060-667-72781-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address75 EXECUTIVE DR, STE 114
Aurora, IL 60504 US
Establishment Type
  • Export Device to the United States But Perform No Other Operation on Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Manufacture Medical Device



FDA Filings

Device
Company
DeviceDate
Careplus (M) SDN BHD
ENCORE Latex Textured Surgical Gloves, Powder Free With Protein Content Labeling Claim (50 Micrograms Or Less) And Tested For Use With Chemotherapy Drugs2021-05-27
Careplus (M) SDN BHD
NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST2017-07-24
Careplus (M) SDN BHD
LATEX EXAMINATION GLOVE POWDER FREE2016-02-25
MANOJ ZACHARIAS [Careplus (M) Sdn Bhd]
NITRILECARE (BLUE)2015-10-27
MANOJ ZACHARIAS [Careplus (M) Sdn Bhd]
Nitrilecare (White)2015-10-27
Careplus (M) SDN BHD
POWDER FREE NITRILE EXAMINATION GLOVE, WHITE (colored)2015-02-09
Careplus (M) SDN BHD
POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored).2015-01-16
MANOJ ZACHARIAS [Careplus (M) Sdn Bhd]
PA-070886275 - Formula 1 - Pdr - Sm2014-03-19
MANOJ ZACHARIAS [Careplus (M) Sdn Bhd]
PA-070886267 - Formula 1 - Pdr - Lg2014-03-19
MANOJ ZACHARIAS [Careplus (M) Sdn Bhd]
PA-070886259 - Formula 1 - Pdr - Med2014-03-19
MANOJ ZACHARIAS [Careplus (M) Sdn Bhd]
PA-070886259 - Formula 1 - Pdr - Med,2014-03-19
MANOJ ZACHARIAS [Careplus (M) Sdn Bhd]
CR-MSC - Formula 1 - Pdr - Sm2014-03-19
MANOJ ZACHARIAS [Careplus (M) Sdn Bhd]
CR-MMC - Formula 1 - Pdr - Med2014-03-19
MANOJ ZACHARIAS [Careplus (M) Sdn Bhd]
CR-MLC - Formula 1 - Pdr - Lg2014-03-19
MANOJ ZACHARIAS [Careplus (M) Sdn Bhd]
6104 - Formula One Latex Exam Glove - L - NS2014-03-19
MANOJ ZACHARIAS [Careplus (M) Sdn Bhd]
6103 - Formula One Latex Exam Glove -Unisize - NS2014-03-19
MANOJ ZACHARIAS [Careplus (M) Sdn Bhd]
6102 - Formula One Latex Exam Glove - S - NS2014-03-19
MANOJ ZACHARIAS [Careplus (M) Sdn Bhd]
6204 - Ultracare Latex Exam Glove - L - NS2014-03-19
MANOJ ZACHARIAS [Careplus (M) Sdn Bhd]
6203 - Ultracare Latex Exam Glove - Unisize - NS2014-03-19
MANOJ ZACHARIAS [Careplus (M) Sdn Bhd]
6202 - Ultracare Latex Exam Glove - S - NS2014-03-19

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092813263Port Swettenham,Malaysia -> New York/Newark Area, Newark, New Jersey245MM POWDER FREE INDIGO NITRILE GLOVES VULCAN POWDER FREE BRAND PACKING 150 PCS DISPENSER, 12 DISPENSER CARTON OUR ITEM CODE FG-NI24PFT2-M00-C-2 OUR ITEM CODE FG-NI24PFT2-L00-C-2 245MM POWDER FREE INDIGO NITRILE GLOVES VULCAN POWDER FREE BRAND PACKING 150 PCS DISPENSER, 9 DISPENSER1550 CTN
2020092813264Port Swettenham,Malaysia -> New York/Newark Area, Newark, New Jersey245MM POWDER FREE INDIGO NITRILE GLOVES VULCAN POWDER FREE BRAND PACKING 150 PCS DISPENSER, 12 DISPENSER CARTON OUR ITEM CODE FG-NI24PFT2-M00-C-2 OUR ITEM CODE FG-NI24PFT2-L00-C-2 245MM POWDER FREE INDIGO NITRILE GLOVES VULCAN POWDER FREE BRAND PACKING 150 PCS DISPENSER, 9 DISPENSER1550 CTN
2020092611652Singapore,Singapore -> Tacoma, WashingtonGLOVES2400 CTN
2020092428449Port Swettenham,Malaysia -> New York/Newark Area, Newark, New Jersey240MM POWDER FREE INDIGO NITRILE GLOVES VULCAN POWDER FREE BRAND PACKING 150 PCS DISPENSER, 12 DISPENSER CARTON OUR ITEM CODE FG-NI24PFT2-M00-C-2 OUR ITEM CODE FG-NI24PFT2-L00-C-2 240MM POWDER FREE INDIGO NITRILE GLOVES VULCAN POWDER FREE BRAND PACKING 150 PCS DISPENSER, 9 DISPENSER1550 CTN
2020092428448Port Swettenham,Malaysia -> New York/Newark Area, Newark, New Jersey240MM POWDER FREE INDIGO NITRILE GLOVES VULCAN POWDER FREE BRAND PACKING 150 PCS DISPENSER, 12 DISPENSER CARTON OUR ITEM CODE FG-NI24PFT2-M00-C-2 OUR ITEM CODE FG-NI24PFT2-L00-C-2 240MM POWDER FREE INDIGO NITRILE GLOVES VULCAN POWDER FREE BRAND PACKING 150 PCS DISPENSER, 9 DISPENSER1550 CTN
2020092310930Singapore,Singapore -> Tacoma, WashingtonGLOVES2400 CTN
2020091741079Port Swettenham,Malaysia -> New York/Newark Area, Newark, New Jersey245MM POWDER FREE INDIGO NITRILE GLOVES VULCAN POWDER FREE BRAND PACKING 150 PCS DISPENSER, 12 DISPENSER CARTON OUR ITEM CODE FG-NI24PFT2-M00-C-2 OUR ITEM CODE FG-NI24PFT2-L00-C-2 245MM POWDER FREE INDIGO NITRILE GLOVES VULCAN POWDER FREE BRAND PACKING 150 PCS DISPENSER, 9 DISPENSER1550 CTN
2020091741078Port Swettenham,Malaysia -> New York/Newark Area, Newark, New Jersey245MM POWDER FREE INDIGO NITRILE GLOVES VULCAN POWDER FREE BRAND PACKING 150 PCS DISPENSER, 12 DISPENSER CARTON OUR ITEM CODE FG-NI24PFT2-M00-C-2 OUR ITEM CODE FG-NI24PFT2-L00-C-2 245MM POWDER FREE INDIGO NITRILE GLOVES VULCAN POWDER FREE BRAND PACKING 150 PCS DISPENSER, 9 DISPENSER1550 CTN

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