Itl Health Group

FDA Filings

This page includes the latest FDA filings for Itl Health Group. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3003895930
• FEI Number: 3011649541
• Name: ITL ASIA PACIFIC SDN BHD
• Owner & Operator: ITL Health Group
• Contact Address: Level 3 10 Moore Street; Canberra AU-ACT Australian Capital Territory 2601 AU
• Official Correspondent:
  • Narinder Kanda
  • 61-3-9088-7999
• US Agent:
  • Susan Finneran
  • REGULATORY COMPLIANCE EXPERTS, INC.
  • 781 6640074
  • sue.finneran@gmail.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Plot 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	Device	Date
PMN BK170102 | KSS ITL ASIA PACIFIC SDN BHD [ITL Health Group]	Samplok Segment Sampler	2019-02-25
KST ITL ASIA PACIFIC SDN BHD [ITL Health Group]	CompoSampler	2017-08-22
FSM ITL ASIA PACIFIC SDN BHD [ITL Health Group]	A500103 Sharps Passing Tray	2016-07-25
FSM ITL ASIA PACIFIC SDN BHD [ITL Health Group]	A500102	2016-07-25
FSM ITL ASIA PACIFIC SDN BHD [ITL Health Group]	A500101 Needle Mat	2016-07-25
PMN K153472 | HAM ITL ASIA PACIFIC SDN BHD [ITL Health Group]	Quiver Extendable A100604	2016-07-08
PMN K153472 | HAM ITL ASIA PACIFIC SDN BHD [ITL Health Group]	Quiver 100398	2016-07-08
PMN K991404 | FMI ITL ASIA PACIFIC SDN BHD [ITL Health Group]	Platypus AV Fistula Needle Guard	2009-05-22
PMN K991404 | FMI ITL ASIA PACIFIC SDN BHD [ITL Health Group]	A100360	2009-05-22
LXG ITL ASIA PACIFIC SDN BHD [ITL Health Group]	TiMO Test Tube Management Device	2008-08-06
LXG ITL ASIA PACIFIC SDN BHD [ITL Health Group]	C100400	2008-08-06
LIB ITL ASIA PACIFIC SDN BHD [ITL Health Group]	Subculture unit	2008-07-11
LIB ITL ASIA PACIFIC SDN BHD [ITL Health Group]	A100730	2008-07-11
LIB ITL ASIA PACIFIC SDN BHD [ITL Health Group]	A100722	2008-07-11
LIB ITL ASIA PACIFIC SDN BHD [ITL Health Group]	A100720	2008-07-11
PMN BK030087 | KSS ITL ASIA PACIFIC SDN BHD [ITL Health Group]	SampLok Sampling Kit SSK	2007-12-07
PMN BK030087 | KSS ITL ASIA PACIFIC SDN BHD [ITL Health Group]	SampLok Sampling Kit SSK Mk3	2007-12-07
PMN BK030087 | KSS ITL ASIA PACIFIC SDN BHD [ITL Health Group]	SampLok Sampling Kit SSK Mk2	2007-12-07
PMN BK030087 | KSS ITL ASIA PACIFIC SDN BHD [ITL Health Group]	A100757	2007-12-07
PMN BK030087 | KSS ITL ASIA PACIFIC SDN BHD [ITL Health Group]	A100754	2007-12-07
PMN BK030087 | KSS ITL ASIA PACIFIC SDN BHD [ITL Health Group]	A100752	2007-12-07
PMN BK030087 | KSS ITL ASIA PACIFIC SDN BHD [ITL Health Group]	A100751	2007-12-07
PMN BK030087 | KSS ITL ASIA PACIFIC SDN BHD [ITL Health Group]	A100750	2007-12-07
PMN BK030087 | KSS ITL ASIA PACIFIC SDN BHD [ITL Health Group]	A100740	2007-12-07
PMN K021941 | JKA ITL ASIA PACIFIC SDN BHD [ITL Health Group]	SampLok System	2007-11-09
PMN K021941 | JKA ITL ASIA PACIFIC SDN BHD [ITL Health Group]	SampLok Safety Adapter Cap w/ Luer	2007-11-09
PMN K021941 | JKA ITL ASIA PACIFIC SDN BHD [ITL Health Group]	SampLok Luer Kit	2007-11-09
PMN K021941 | JKA ITL ASIA PACIFIC SDN BHD [ITL Health Group]	A100710	2007-11-09
PMN K021941 | JKA ITL ASIA PACIFIC SDN BHD [ITL Health Group]	A100704	2007-11-09
PMN K021941 | JKA ITL ASIA PACIFIC SDN BHD [ITL Health Group]	A100645	2007-11-09
PMN K021941 | JKA ITL ASIA PACIFIC SDN BHD [ITL Health Group]	A100500	2007-11-09
PMN K021941 | FMI ITL ASIA PACIFIC SDN BHD [ITL Health Group]	SampLok System	2007-11-09
PMN K021941 | FMI ITL ASIA PACIFIC SDN BHD [ITL Health Group]	SampLok Safety Adapter Cap w/ Luer	2007-11-09
PMN K021941 | FMI ITL ASIA PACIFIC SDN BHD [ITL Health Group]	SampLok Luer Kit	2007-11-09
PMN K021941 | FMI ITL ASIA PACIFIC SDN BHD [ITL Health Group]	A100710	2007-11-09
PMN K021941 | FMI ITL ASIA PACIFIC SDN BHD [ITL Health Group]	A100704	2007-11-09
PMN K021941 | FMI ITL ASIA PACIFIC SDN BHD [ITL Health Group]	A100645	2007-11-09
PMN K021941 | FMI ITL ASIA PACIFIC SDN BHD [ITL Health Group]	A100500	2007-11-09
PMN K000777 | JKA ITL ASIA PACIFIC SDN BHD [ITL Health Group]	Samplok	2007-11-09
PMN K000777 | JKA ITL ASIA PACIFIC SDN BHD [ITL Health Group]	A100763	2007-11-09
PMN K000777 | JKA ITL ASIA PACIFIC SDN BHD [ITL Health Group]	A100762	2007-11-09
PMN K000777 | JKA ITL ASIA PACIFIC SDN BHD [ITL Health Group]	A100761	2007-11-09
PMN K000777 | JKA ITL ASIA PACIFIC SDN BHD [ITL Health Group]	A100760	2007-11-09
PMN K000777 | JKA ITL ASIA PACIFIC SDN BHD [ITL Health Group]	A100718	2007-11-09
PMN K000777 | JKA ITL ASIA PACIFIC SDN BHD [ITL Health Group]	A100715	2007-11-09
PMN K000777 | JKA ITL ASIA PACIFIC SDN BHD [ITL Health Group]	A100709	2007-11-09
PMN K000777 | JKA ITL ASIA PACIFIC SDN BHD [ITL Health Group]	A100706	2007-11-09
PMN K000777 | JKA ITL ASIA PACIFIC SDN BHD [ITL Health Group]	A100648	2007-11-09
PMN K000777 | JKA ITL ASIA PACIFIC SDN BHD [ITL Health Group]	A100643	2007-11-09
PMN K000777 | JKA ITL ASIA PACIFIC SDN BHD [ITL Health Group]	A100422	2007-11-09
PMN K000777 | JKA ITL ASIA PACIFIC SDN BHD [ITL Health Group]	A100400	2007-11-09
PMN BK980008 | KSS ITL ASIA PACIFIC SDN BHD [ITL Health Group]	Donor Care Bloodpack Needle Protect	2007-11-09
PMN BK980008 | KSS ITL ASIA PACIFIC SDN BHD [ITL Health Group]	A100150	2007-11-09
PMN BK980008 | KSS ITL ASIA PACIFIC SDN BHD [ITL Health Group]	A100100	2007-11-09
KSD ITL ASIA PACIFIC SDN BHD [ITL Health Group]	CROCCLAMP(TM)	2007-03-12
KSD ITL ASIA PACIFIC SDN BHD [ITL Health Group]	A100111	2007-03-12
KSD ITL ASIA PACIFIC SDN BHD [ITL Health Group]	100111R	2007-03-12