Itl Asia Pacific Sdn Bhd

FDA Filings

This page includes the latest FDA filings for Itl Asia Pacific 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 Number3003895930
FEI Number3011649541
NameITL ASIA PACIFIC SDN BHD
Owner & OperatorITL Health Group
Contact AddressLevel 3 10 Moore Street
Canberra AU-ACT Australian Capital Territory 2601 AU
Official Correspondent
  • Narinder Kanda
  • 61-3-9088-7999
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressPlot 17B, Lorong Bemban 2 Bemban Industrial Estate
Batu Gajah Perak, 31000 MY
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device
Company
DeviceDate
ITL ASIA PACIFIC SDN. BHD.
 SCU Wide Cap Sampler A1007232024-12-19
ITL ASIA PACIFIC SDN. BHD.
 Segment Sampler (SEG) A2002002024-08-08
ITL ASIA PACIFIC SDN. BHD.
 ITL Essentials™ Tourniquet B&B Thick Strap 45cm NS A6000012023-12-19
ITL ASIA PACIFIC SDN. BHD.
 ITL Essentials™ Sharps Passing Tray Large NS A5001162023-07-27
ITL ASIA PACIFIC SDN. BHD.
 ITL Essentials™ Sharps Passing Tray Large A5001172023-07-27
ITL ASIA PACIFIC SDN. BHD.
 IV Start Kit IVSK1002023-07-06
ITL ASIA PACIFIC SDN. BHD.
 ITL Essentials™ Sharps Passing Tray, Sterile A5001032022-03-22
ITL ASIA PACIFIC SDN. BHD.
 TiMO™ Tube Management Holder 2021-06-28
ITL ASIA PACIFIC SDN. BHD.
 Safety SubCulture Unit 2 (SCU2) A1007222021-01-22
ITL ASIA PACIFIC SDN. BHD.
 Safety SubCulture Unit (SCU) A1007202021-01-22
ITL ASIA PACIFIC SDN. BHD.
 ITL Essentials™ Needle Mat (Sterile) A5001012020-10-21
ITL ASIA PACIFIC SDN. BHD.
 SampLok® Sampling Kit 35mL A1007522020-10-09
ITL ASIA PACIFIC SDN. BHD.
 SampLok® Sampling Kit 20mL A1007542020-03-09
ITL ASIA PACIFIC SDN. BHD.
 Transfer Cap Set A1007302020-03-09
ITL ASIA PACIFIC SDN. BHD.
 ITL Essential Laparoscopic Quiver Extendable A1006042019-06-03
ITL ASIA PACIFIC SDN. BHD.
 ITL Essential Standard Quiver A1003982019-06-03
ITL ASIA PACIFIC SDN. BHD.
 SampLok® System with Hinged Lid A1006482019-05-31
ITL ASIA PACIFIC SDN. BHD.
 SampLok® Adapter Cap 3 Insert A1007632019-04-23
ITL ASIA PACIFIC SDN. BHD.
 SampLok® Adapter Cap 3 A1007622019-04-23
ITL ASIA PACIFIC SDN. BHD.
 SampLok® Adapter Cap 3 Insert A1007612019-04-23
ITL ASIA PACIFIC SDN. BHD.
 SampLok® Adapter Cap 3 A1007602019-04-23
ITL ASIA PACIFIC SDN. BHD.
 SampLok® Adapter Cap 2 A1007182019-04-23
ITL ASIA PACIFIC SDN. BHD.
 SampLok® Adapter Cap 2 A1007152019-04-23
ITL ASIA PACIFIC SDN. BHD.
 SampLok® Adapter Cap A1007062019-04-23
ITL ASIA PACIFIC SDN. BHD.
 SampLok® Adapter Cap Kit A1007042019-04-23
ITL ASIA PACIFIC SDN. BHD.
 SampLok® A1004002019-04-23
ITL ASIA PACIFIC SDN. BHD.
 SampLok® System with Hinged Lid A1006432019-04-23
ITL ASIA PACIFIC SDN. BHD.
 SampLok® With Hinged Lid A1004222019-04-23
ITL ASIA PACIFIC SDN. BHD.
 SampLok® Adapter Cap Insert A1007092019-04-23
ITL ASIA PACIFIC SDN. BHD.
 SampLok® Sampling Kit 10mL A1007502019-04-08
ITL ASIA PACIFIC SDN. BHD.
 SampLok® Sampling Kit 16mL A1007402019-04-08
ITL ASIA PACIFIC SDN. BHD.
 Platypus® AV Fistula Needle Guard A1003602019-04-08
ITL ASIA PACIFIC SDN. BHD.
 SampLok® Safety Adapter Cap with male luer A1007102019-04-08
ITL ASIA PACIFIC SDN. BHD.
 SampLok® System with No Lid A1005002019-04-08
ITL ASIA PACIFIC SDN. BHD.
 SampLok® System with Hinged Lid A1006452019-04-08
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
Samplok Segment Sampler2019-02-25
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
CompoSampler2017-08-22
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
A500103 Sharps Passing Tray2016-07-25
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
A5001022016-07-25
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
A500101 Needle Mat2016-07-25
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
Quiver Extendable A1006042016-07-08
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
Quiver 1003982016-07-08
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
Platypus AV Fistula Needle Guard2009-05-22
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
A1003602009-05-22
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
TiMO Test Tube Management Device2008-08-06
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
C1004002008-08-06
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
Subculture unit2008-07-11
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
A1007302008-07-11
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
A1007222008-07-11
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
A1007202008-07-11
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
SampLok Sampling Kit SSK2007-12-07
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
SampLok Sampling Kit SSK Mk32007-12-07
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
SampLok Sampling Kit SSK Mk22007-12-07
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
A1007572007-12-07
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
A1007542007-12-07
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
A1007522007-12-07
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
A1007512007-12-07
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
A1007502007-12-07
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
A1007402007-12-07
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
SampLok System2007-11-09
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
SampLok Safety Adapter Cap w/ Luer2007-11-09
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
SampLok Luer Kit2007-11-09
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
A1007102007-11-09
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
A1007042007-11-09
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
A1006452007-11-09
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
A1005002007-11-09
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
SampLok System2007-11-09
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
SampLok Safety Adapter Cap w/ Luer2007-11-09
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
SampLok Luer Kit2007-11-09
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
A1007102007-11-09
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
A1007042007-11-09
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
A1006452007-11-09
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
A1005002007-11-09
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
Samplok2007-11-09
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
A1007632007-11-09
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
A1007622007-11-09
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
A1007612007-11-09
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
A1007602007-11-09
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
A1007182007-11-09
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
A1007152007-11-09
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
A1007092007-11-09
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
A1007062007-11-09
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
A1006482007-11-09
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
A1006432007-11-09
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
A1004222007-11-09
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
A1004002007-11-09
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
Donor Care Bloodpack Needle Protect2007-11-09
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
A1001502007-11-09
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
A1001002007-11-09
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
CROCCLAMP(TM)2007-03-12
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
A1001112007-03-12
ITL ASIA PACIFIC SDN BHD [ITL Health Group]
100111R2007-03-12

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
202009261847Port Swettenham,Malaysia -> Norfolk, VirginiaSHL WB(11-18)TITAN CLEAR + PP NIPRO LUER(S)-(A100645) SAMPLOK SYSTEMS Y SITES (A100500) PLATYPUS NEEDLEGUARD-BOREALIS CLEAR (BULK)-(BOX/1200)(A100360)735 CTN
2020092453284Port Swettenham,Malaysia -> Norfolk, VirginiaFTB HOLDER W. PP LUER (6R4011) SAFETY SUBCULTURE UNIT BOX=360 (A100720) SAMPLOK SAMPLING KIT - MK3RF - 20ML (A100759) TEGO SWINE ORAL FLUIDS COLLECTION KIT (A100930) TRANSFER CAP SET (A100730)1450 CTN
2020092221020Port Swettenham,Malaysia -> Norfolk, VirginiaSHL WB (11-18) TITAN CLEAR + PP NIPRO LUER (S)(A100645) PLATYPUS NEEDLEGUARD-BOREALIS CLEAR (BULK)-(BOX/1200)(A100360)735 CTN
2020091619268Port Swettenham,Malaysia -> Norfolk, VirginiaFTB HOLDER W. PP LUER (6R4011) SAFETY SUBCULTURE UNIT (CT360)(A100720) SAMPLOK SAMPLING KIT - MK3 - 20ML (A100754)1680 CTN
202009077803Port Swettenham,Malaysia -> Norfolk, VirginiaDONORCARE NEEDLE GUARD SC(A100100) FTB HOLDER W.PP LUER (6R4011) SAFETY SUBCULTURE UNIT BOX=360(A100720) SAMPLOK SAMPLING KIT-MK3-20ML(A100754)1470 CTN
2020082522314Port Swettenham,Malaysia -> Norfolk, VirginiaDONORCARE NEEDLE GUARD SC (A100100) FTB HOLDER W.PP LUER (6R4011) SAMPLOK SAMPLING KIT-MK3-20ML (A100754)735 CTN
2020081424804Port Swettenham,Malaysia -> Norfolk, VirginiaSHL WB(11-18)TITAN CLEAR + PP NIPRO LUER(S)-(A100645) SAMPLOK SYSTEMS Y SITES (A100500) PLATYPUS NEEDLEGUARD-BOREALIS CLEAR (BULK)-(BOX/1200)(A100360)735 CTN
2020081024365Port Swettenham,Malaysia -> Norfolk, VirginiaSAMPLOK (R) SAMPLING KIT-MK3RF-10ML (A100751) FTB HOLDER W. PP LUER (6R4011) SAFETY SUBCULTURE UNIT (CS360) (A100720) SAMPLOK SAMPLING KIT-MK3-20ML (A100754)1291 CTN
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