Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003895930

FEI Number

3011649541

Entity Name

ITL ASIA PACIFIC SDN BHD

City/State/Country

Batu Gajah Perak, MY

Establishment Address

Plot 17B, Lorong Bemban 2, Bemban Industrial Estate, Batu Gajah Perak 31000, MY

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ITL Health Group (Owner Number: 9033436)

Owner / Operator Contact Address

Level 3, 59 Wentworth Ave, Kingston, AU-ACT 2604, AU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

A100645 A100704 A100710 A100500 A100111 A100111R A100398 A100604 A100760 A100761 A100648 A100643 A100706 A100400 A100422 A100780 IVSK100 A600001 A100754 A100740 A100756 A100750 A100360 A500103 A500117 A500116 A500102

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2007-11-09
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2007-11-09
KSD	Device, Heat-Sealing	Hematology	Class 1	864.9750	2007-03-12
HAM	Apparatus, Electrosurgical	General, Plastic Surgery	Class 2	878.4400	2016-07-08
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2007-11-09
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2026-06-16
LRS	I.V. Start Kit	General Hospital	Class 2	880.5200	2023-05-09
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2021-12-11
KSS	Supplies, Blood-Bank	Hematology	Class 1	864.9050	2007-12-07
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2009-05-22
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2016-07-25

Official Correspondent

Narinder Kanda

US Agent Details

Susan Finneran Business: REGULATORY COMPLIANCE EXPERTS, INC. Email: sue.finneran@gmail.com Phone: (781) 6640074

Related Public Records

Same Entity

ITL Health Group

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K945777	Smiths Industries Medical Systems, Inc.	PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES	1994-12-22
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-2014	Perkin Elmer Health Sciences, Inc.	2	Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003895930. Last updated year: 2026. Please use registration number 3003895930 when referencing this establishment in official correspondence.