Central Medicare Sdn Bhd

FDA Filings

This page includes the latest FDA filings for Central Medicare 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 Number3008253024
FEI Number3008253024
NameRene van de Zande
Owner & OperatorCentral Medicare Sdn Bhd
Contact AddressPlot 2609-2620, Batu 8, Jalan Changkat J
Teluk Intan MY-08 Perak 36000 MY
Official Correspondent
  • Muhammad Abdul Rahman
  • 60-05-6290000-x
US Agent
Importing Logistics Registration
ImporterNeogen Mercer Rd Distribution
Address1847 Mercer Rd Dock #16
Lexington, KY 40511 UNITED STATES
Phone1 859 4558018
Importing Logistics Registration
ImporterPacific Merchants Alliance, LLC
Address13800 Coppermine Road
Herndon, VA 20171 UNITED STATES
Importing Logistics Registration
ImporterRadnor
AddressRadnor
Chesterbrook, PA 19087 UNITED STATES
Importing Logistics Registration
ImporterTAC Total Automation Controls, Inc.
Address9155 Billy The Kid St.
El Paso, TX 79907 UNITED STATES
Phone1 915 7901083
FAX1 915 8720532
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2500 Bee Cave Road Bldg 1, Suite 300
Austin, TX 78746 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)



FDA Filings

Device
Company
DeviceDate
Central Medicare Sdn Bhd
Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs, With Gastric Acid And Fentanyl Permeation Resistance Claims.2021-12-22
Central Medicare Sdn Bhd
Non Sterile Powder Free Polyurethane Examination Gloves (Blue And Black Colors)2021-05-07
Rene van de Zande [Central Medicare Sdn Bhd]
Sterling Nitrile Xtra Powder Free Non Sterile Exam Glove2020-02-20
Rene van de Zande [Central Medicare Sdn Bhd]
Lavender Nitrile Exam Gloves2019-10-13
Rene van de Zande [Central Medicare Sdn Bhd]
Lavender Nitrile Exam Gloves2019-10-13
Rene van de Zande [Central Medicare Sdn Bhd]
Blue Non Sterile Powder Free Nitrile Examination Gloves (with Chemo Drugs, Low Dermatitis and Fentanyl Claims)2019-07-09
Rene van de Zande [Central Medicare Sdn Bhd]
Aquasoft Zero Powder Free Nitrile Exam Gloves2019-07-09
Rene van de Zande [Central Medicare Sdn Bhd]
8773A Safety First Nitrile Exam Gloves2019-07-09
Rene van de Zande [Central Medicare Sdn Bhd]
8723 Elite Protective Nitrile Exam Gloves2019-07-09
Rene van de Zande [Central Medicare Sdn Bhd]
8713 HyperFlex Nitrile Exam Gloves2019-07-09
Rene van de Zande [Central Medicare Sdn Bhd]
Blue Non Sterile Powder Free Nitrile Examination Gloves (with Chemo Drugs, Low Dermatitis and Fentanyl Claims)2019-07-09
Rene van de Zande [Central Medicare Sdn Bhd]
Aquasoft Zero Powder Free Nitrile Exam Gloves2019-07-09
Rene van de Zande [Central Medicare Sdn Bhd]
8773A Safety First Nitrile Exam Gloves2019-07-09
Rene van de Zande [Central Medicare Sdn Bhd]
8723 Elite Protective Nitrile Exam Gloves2019-07-09
Rene van de Zande [Central Medicare Sdn Bhd]
8713 HyperFlex Nitrile Exam Gloves2019-07-09
Rene van de Zande [Central Medicare Sdn Bhd]
Blue Non Sterile Powder Free Nitrile Examination Gloves (with Chemo Drugs, Low Dermatitis and Fentanyl Claims)2019-07-09
Rene van de Zande [Central Medicare Sdn Bhd]
Aquasoft Zero Powder Free Nitrile Exam Gloves2019-07-09
Rene van de Zande [Central Medicare Sdn Bhd]
8773A Safety First Nitrile Exam Gloves2019-07-09
Rene van de Zande [Central Medicare Sdn Bhd]
8723 Elite Protective Nitrile Exam Gloves2019-07-09
Rene van de Zande [Central Medicare Sdn Bhd]
8713 HyperFlex Nitrile Exam Gloves2019-07-09
Central Medicare Sdn. Bhd.
Blue Non-Sterile Powder Free Nitrile Examination Gloves, Tested For Use With Low Dermatitis And Fentanyl Permeation Resistance Claim2019-07-04
Rene van de Zande [Central Medicare Sdn Bhd]
Lavender Nitrile Exam Gloves2018-11-16
Rene van de Zande [Central Medicare Sdn Bhd]
SensiCare Silk-SmartGuard2018-06-21
Rene van de Zande [Central Medicare Sdn Bhd]
Parkland2018-06-21
Rene van de Zande [Central Medicare Sdn Bhd]
FitGuard2018-06-21
Rene van de Zande [Central Medicare Sdn Bhd]
FitGuard ES2018-06-21
Rene van de Zande [Central Medicare Sdn Bhd]
FitGuard BCH4002018-06-21
Rene van de Zande [Central Medicare Sdn Bhd]
UniSeal Nitrile Pro 7002018-03-06
Rene van de Zande [Central Medicare Sdn Bhd]
Radnor Nitrile Exam PF 8mil2018-03-06
Rene van de Zande [Central Medicare Sdn Bhd]
Radnor 6405729x2018-03-06
Rene van de Zande [Central Medicare Sdn Bhd]
Premier Pro Plus 5064 Nitrile Exam Gloves2018-03-06
Rene van de Zande [Central Medicare Sdn Bhd]
Premier Pro Nitrile Exam Gloves2018-03-06
Rene van de Zande [Central Medicare Sdn Bhd]
Nytrile X300 Electra Blue Powder Free Nitrile Exam Gloves2018-03-06
Rene van de Zande [Central Medicare Sdn Bhd]
Nitri-Sure Powder-Free Nitrile Exam Gloves2018-03-06
Rene van de Zande [Central Medicare Sdn Bhd]
Microflex Integra EC2018-03-06
Rene van de Zande [Central Medicare Sdn Bhd]
Medichoice Super Sleek Nitrile Exam Glove2018-03-06
Rene van de Zande [Central Medicare Sdn Bhd]
Medichoice Glove Exam Steel Blue2018-03-06
Rene van de Zande [Central Medicare Sdn Bhd]
Medichoice Glove Exam Nitrile XT2018-03-06
Rene van de Zande [Central Medicare Sdn Bhd]
Criterion N300 Ultra Powder Free Nitrile Exam Gloves2018-03-06
Rene van de Zande [Central Medicare Sdn Bhd]
Confiderm Nitrile Examination Gloves2018-03-06
Rene van de Zande [Central Medicare Sdn Bhd]
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs2018-03-06
Rene van de Zande [Central Medicare Sdn Bhd]
Better Touch2018-03-06
Rene van de Zande [Central Medicare Sdn Bhd]
Avianz Nitrile Examination Gloves2018-03-06
Rene van de Zande [Central Medicare Sdn Bhd]
Aquasoft Powder-free Nitrile Exam Gloves2018-03-06
Rene van de Zande [Central Medicare Sdn Bhd]
Accutouch Chemo2018-03-06
Rene van de Zande [Central Medicare Sdn Bhd]
8723 Elite Protective2018-03-06
Rene van de Zande [Central Medicare Sdn Bhd]
8720 Elite Protective Extra2018-03-06
Rene van de Zande [Central Medicare Sdn Bhd]
8713 HyperFlex2018-03-06
Rene van de Zande [Central Medicare Sdn Bhd]
UniSeal Nitrile Pro 7002018-03-06
Rene van de Zande [Central Medicare Sdn Bhd]
Radnor Nitrile Exam PF 8mil2018-03-06
Rene van de Zande [Central Medicare Sdn Bhd]
Radnor 6405729x2018-03-06
Rene van de Zande [Central Medicare Sdn Bhd]
Premier Pro Plus 5064 Nitrile Exam Gloves2018-03-06
Rene van de Zande [Central Medicare Sdn Bhd]
Premier Pro Nitrile Exam Gloves2018-03-06
Rene van de Zande [Central Medicare Sdn Bhd]
Nytrile X300 Electra Blue Powder Free Nitrile Exam Gloves2018-03-06
Rene van de Zande [Central Medicare Sdn Bhd]
Nitri-Sure Powder-Free Nitrile Exam Gloves2018-03-06
Rene van de Zande [Central Medicare Sdn Bhd]
Microflex Integra EC2018-03-06
Rene van de Zande [Central Medicare Sdn Bhd]
Medichoice Super Sleek Nitrile Exam Glove2018-03-06
Rene van de Zande [Central Medicare Sdn Bhd]
Medichoice Glove Exam Steel Blue2018-03-06
Rene van de Zande [Central Medicare Sdn Bhd]
Medichoice Glove Exam Nitrile XT2018-03-06
Rene van de Zande [Central Medicare Sdn Bhd]
Criterion N300 Ultra Powder Free Nitrile Exam Gloves2018-03-06
Rene van de Zande [Central Medicare Sdn Bhd]
Confiderm Nitrile Examination Gloves2018-03-06
Rene van de Zande [Central Medicare Sdn Bhd]
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs2018-03-06
Rene van de Zande [Central Medicare Sdn Bhd]
Better Touch2018-03-06
Rene van de Zande [Central Medicare Sdn Bhd]
Avianz Nitrile Examination Gloves2018-03-06
Rene van de Zande [Central Medicare Sdn Bhd]
Aquasoft Powder-free Nitrile Exam Gloves2018-03-06
Rene van de Zande [Central Medicare Sdn Bhd]
Accutouch Chemo2018-03-06
Rene van de Zande [Central Medicare Sdn Bhd]
8723 Elite Protective2018-03-06
Rene van de Zande [Central Medicare Sdn Bhd]
8720 Elite Protective Extra2018-03-06
Rene van de Zande [Central Medicare Sdn Bhd]
8713 HyperFlex2018-03-06
Central Medicare Sdn. Bhd.
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs2018-03-05
Rene van de Zande [Central Medicare Sdn Bhd]
HALYARD* Purple Nitrile* Powder Free Exam Textured 9.5? Glove2018-01-30
Rene van de Zande [Central Medicare Sdn Bhd]
HALYARD* Purple Nitrile* Powder Free Exam Textured 9.5? Glove2018-01-30
Rene van de Zande [Central Medicare Sdn Bhd]
Orange Non Sterile Powder Free Nitrile Examination Gloves2017-12-13
Rene van de Zande [Central Medicare Sdn Bhd]
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs2017-12-13
Rene van de Zande [Central Medicare Sdn Bhd]
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs2017-12-13
Central Medicare Sdn. Bhd.
Orange Non Sterile Powder Free Nitrile Examination Gloves2017-11-28
Central Medicare Sdn. Bhd.
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs2017-11-13
Rene van de Zande [Central Medicare Sdn Bhd]
Sterling SG Nitrile2017-11-13
Rene van de Zande [Central Medicare Sdn Bhd]
Sterling SG Nitrile Eco Pull2017-11-13
Rene van de Zande [Central Medicare Sdn Bhd]
Sterling Nitrile Exam Gloves2017-11-13
Rene van de Zande [Central Medicare Sdn Bhd]
X-Factor Scientific Nitrile Examination Gloves2015-01-26
Rene van de Zande [Central Medicare Sdn Bhd]
Trufit Ultra Thin Nitrile Violet2015-01-26
Rene van de Zande [Central Medicare Sdn Bhd]
Trufit Ultra Thin Nitrile Seashell White2015-01-26
Rene van de Zande [Central Medicare Sdn Bhd]
Tronex 92522015-01-26
Rene van de Zande [Central Medicare Sdn Bhd]
Tronex 92502015-01-26
Rene van de Zande [Central Medicare Sdn Bhd]
Tronex 9210UNI2015-01-26
Rene van de Zande [Central Medicare Sdn Bhd]
TAC Powder Free White Nitrile Gloves2015-01-26
Rene van de Zande [Central Medicare Sdn Bhd]
TAC Blue Nitrile Gloves (4.0g)2015-01-26
Rene van de Zande [Central Medicare Sdn Bhd]
Surecare White2015-01-26
Rene van de Zande [Central Medicare Sdn Bhd]
Surecare Blue2015-01-26
Rene van de Zande [Central Medicare Sdn Bhd]
Surecare Black2015-01-26
Rene van de Zande [Central Medicare Sdn Bhd]
SureCare Blue 8 Mil2015-01-26
Rene van de Zande [Central Medicare Sdn Bhd]
Supernova2015-01-26
Rene van de Zande [Central Medicare Sdn Bhd]
SimplySafe Blue2015-01-26
Rene van de Zande [Central Medicare Sdn Bhd]
SAS Derma-Lite2015-01-26
Rene van de Zande [Central Medicare Sdn Bhd]
SAS Derma Max2015-01-26
Rene van de Zande [Central Medicare Sdn Bhd]
Radnor2015-01-26
Rene van de Zande [Central Medicare Sdn Bhd]
ProWorks? Black Nitrile Examination Glove2015-01-26
Rene van de Zande [Central Medicare Sdn Bhd]
Premium Touch2015-01-26
Rene van de Zande [Central Medicare Sdn Bhd]
Precision2015-01-26
Rene van de Zande [Central Medicare Sdn Bhd]
Plak Smacker-Trufit Violet2015-01-26
Rene van de Zande [Central Medicare Sdn Bhd]
Plack Smacker-Trufit Seashell White2015-01-26
Rene van de Zande [Central Medicare Sdn Bhd]
Nytrile X300 Electra Blue2015-01-26
Rene van de Zande [Central Medicare Sdn Bhd]
Nytrile X300 Electra Blue Powder Free Nitrile Exam Gloves2015-01-26
Rene van de Zande [Central Medicare Sdn Bhd]
Nytrile White X3002015-01-26
Rene van de Zande [Central Medicare Sdn Bhd]
Nitri-Sure2015-01-26
Rene van de Zande [Central Medicare Sdn Bhd]
Miracle2015-01-26
Rene van de Zande [Central Medicare Sdn Bhd]
Microflex Cobalt X Nitrile Examination Gloves2015-01-26
Rene van de Zande [Central Medicare Sdn Bhd]
Matig Kuervo Black Nitrile2015-01-26
Rene van de Zande [Central Medicare Sdn Bhd]
Kingseal2015-01-26
Rene van de Zande [Central Medicare Sdn Bhd]
HandArmor2015-01-26
Rene van de Zande [Central Medicare Sdn Bhd]
GrizzlyNite2015-01-26
Rene van de Zande [Central Medicare Sdn Bhd]
Gloveon Hammer Black Nitrile2015-01-26
Rene van de Zande [Central Medicare Sdn Bhd]
FitGuard2015-01-26
Rene van de Zande [Central Medicare Sdn Bhd]
FitGuard Ultra2015-01-26
Rene van de Zande [Central Medicare Sdn Bhd]
FitGuard ES2015-01-26
Rene van de Zande [Central Medicare Sdn Bhd]
Fisherbrand2015-01-26
Rene van de Zande [Central Medicare Sdn Bhd]
First Aid Synthetic2015-01-26
Rene van de Zande [Central Medicare Sdn Bhd]
Eclipse Black2015-01-26
Rene van de Zande [Central Medicare Sdn Bhd]
Dermatec Twilight Blue2015-01-26
Rene van de Zande [Central Medicare Sdn Bhd]
Derma-Pro Black Nitrile Powder-Free Nitrile Examination Gloves2015-01-26
Rene van de Zande [Central Medicare Sdn Bhd]
Curaplex TritonGrip VL2015-01-26
Rene van de Zande [Central Medicare Sdn Bhd]
Criterion N300 Ultra2015-01-26
Rene van de Zande [Central Medicare Sdn Bhd]
Criterion N300 Ultra Powder Free Nitrile Gloves2015-01-26
Rene van de Zande [Central Medicare Sdn Bhd]
Cobalt Ultra2015-01-26
Rene van de Zande [Central Medicare Sdn Bhd]
CURAD Powder-Free Nitrile Exam Gloves2015-01-26
Rene van de Zande [Central Medicare Sdn Bhd]
Better Touch2015-01-26
Rene van de Zande [Central Medicare Sdn Bhd]
Better Touch EMS EC Nitrile Examination Gloves2015-01-26
Rene van de Zande [Central Medicare Sdn Bhd]
Aquasoft Powder-free Nitrile Exam Gloves2015-01-26
Rene van de Zande [Central Medicare Sdn Bhd]
9770 Elite Protective2015-01-26
Rene van de Zande [Central Medicare Sdn Bhd]
950 Pasco2015-01-26
Rene van de Zande [Central Medicare Sdn Bhd]
8773A Safety First2015-01-26
Rene van de Zande [Central Medicare Sdn Bhd]
8723 Elite Protective2015-01-26
Rene van de Zande [Central Medicare Sdn Bhd]
8713 HyperFlex2015-01-26
CENTRAL MEDICARE SDN BHD
Powder Free Nitrile Examination Gloves, Nonsterile,(Blue,Black, And White Colored)2015-01-22
Rene van de Zande [Central Medicare Sdn Bhd]
Flexal 88TNF2013-12-17
Rene van de Zande [Central Medicare Sdn Bhd]
Flexal 88LC2013-12-17
Rene van de Zande [Central Medicare Sdn Bhd]
TORQ2012-05-29
Rene van de Zande [Central Medicare Sdn Bhd]
Raven Powder Free Nitrile Examination Gloves2012-05-29
Rene van de Zande [Central Medicare Sdn Bhd]
ProWork? Black Nitrile Examination Glove2012-05-29
Rene van de Zande [Central Medicare Sdn Bhd]
HandArmor2012-05-29
Rene van de Zande [Central Medicare Sdn Bhd]
GrizzlyNite2012-05-29
Rene van de Zande [Central Medicare Sdn Bhd]
First Aid Synthetic2012-05-29
Rene van de Zande [Central Medicare Sdn Bhd]
Elite Protective2012-05-29
Rene van de Zande [Central Medicare Sdn Bhd]
Eclipse2012-05-29
Rene van de Zande [Central Medicare Sdn Bhd]
950 Pasco2012-05-29
CENTRAL MEDICARE SDN BHD
HIGH FIVE2012-05-23
Rene van de Zande [Central Medicare Sdn Bhd]
TAC Powder Free White Nitrile Gloves2011-08-26
CENTRAL MEDICARE SDN BHD
POWDER FREE NITRILE EXAMINATION GLOVES WHITE COLORED NON-STERILE2011-08-19
Rene van de Zande [Central Medicare Sdn Bhd]
Tronex 92522010-02-22
Rene van de Zande [Central Medicare Sdn Bhd]
Tronex 92502010-02-22
Rene van de Zande [Central Medicare Sdn Bhd]
Tronex 9210UNI2010-02-22
Rene van de Zande [Central Medicare Sdn Bhd]
TAC Powder Free Blue Nitrile Gloves2010-02-22
Rene van de Zande [Central Medicare Sdn Bhd]
TAC Blue Nitrile Gloves (4.0g)2010-02-22
Rene van de Zande [Central Medicare Sdn Bhd]
Surecare Blue2010-02-22
Rene van de Zande [Central Medicare Sdn Bhd]
Supernova2010-02-22
Rene van de Zande [Central Medicare Sdn Bhd]
Radnor2010-02-22
Rene van de Zande [Central Medicare Sdn Bhd]
Premium Touch2010-02-22
Rene van de Zande [Central Medicare Sdn Bhd]
Nitri-Sure2010-02-22
Rene van de Zande [Central Medicare Sdn Bhd]
Nitra Care2010-02-22
Rene van de Zande [Central Medicare Sdn Bhd]
Miracle2010-02-22
Rene van de Zande [Central Medicare Sdn Bhd]
Microflex Cobalt X Nitrile Examination Gloves2010-02-22
Rene van de Zande [Central Medicare Sdn Bhd]
Kingseal2010-02-22
Rene van de Zande [Central Medicare Sdn Bhd]
Fisherbrand2010-02-22
Rene van de Zande [Central Medicare Sdn Bhd]
Ag-Tek? True Blue2010-02-22
Rene van de Zande [Central Medicare Sdn Bhd]
8723 Elite Protective2010-02-22
Rene van de Zande [Central Medicare Sdn Bhd]
8720 Elite Protective Extra2010-02-22
Rene van de Zande [Central Medicare Sdn Bhd]
8713 HyperFlex2010-02-22
CENTRAL MEDICARE SDN BHD
SR GLOVE, NU GLOVE, HIGHSTRESS MODEL 801, MODEL 802, MODEL 8032010-02-12

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092935127Singapore,Singapore -> Long Beach, California1 X 40'HC CONTAINER: 2040 CA RTONS NITRILE GLOVES WITH PURCHASE ORDER 18052857 HS CODE: 4015.19.0090 FREIGHT COLLECT -TEL: N/A QA: JUDD BOYD TEL: (901) 619-3360 OM: RANDY HOOVER TEL: +1 (662040 CTN
2020092935189Singapore,Singapore -> Long Beach, California1 X 40'HC CONTAINER: 2160 CA RTONS NITRILE GLOVES WITH PURCHASE ORDER 18052858 HS CODE: 4015.19.0090 FREIGHT COLLECT -TEL: N/A QA: JUDD BOYD TEL: (901) 619-3360 OM: RANDY HOOVER TEL: +1 (662160 CTN
2020092940272Shekou,China (Mainland) -> Los Angeles, CaliforniaGLOVES1800 CTN
2020092634426Port Swettenham,Malaysia -> Los Angeles, CaliforniaGLOVES2160 CTN
2020092518702Port Swettenham,Malaysia -> Los Angeles, CaliforniaGLOVES3220 CTN
202009252813Shanghai ,China (Mainland) -> Long Beach, CaliforniaGLOVES2040 CTN
202009251340Shanghai ,China (Mainland) -> Long Beach, CaliforniaGLOVES1980 CTN
2020092520880Port Swettenham,Malaysia -> Los Angeles, CaliforniaGLOVES2160 CTN

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