Data / Medical devices / Malaysia / Itl Asia Pacific Sdn Bhd
Itl Asia Pacific Sdn Bhd: FDA-registered device maker in Batu Gajah Perak, Malaysia, 4 510(k) clearances
Itl Asia Pacific Sdn Bhd is registered with the FDA (registration 3003895930) in Batu Gajah Perak, Malaysia. It lists 12 device types. The FDA files 4 510(k) clearances under its listings, the newest dated June 23, 2016. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3003895930
- FEI number
- 3011649541
- Address
- Plot 17B, Lorong Bemban 2 Bemban Industrial Estate, Batu Gajah Perak, Malaysia, 31000
- Owner or operator
- ITL Health Group (9033436)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- March 12, 2007
- Registered through
- 2026
- Brand names listed
- 6R4011, A100100, A100111, A100111R, A100150, A100360, A100398, A100400 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apparatus, Electrosurgical | HAM | 2 | Manufacturer | accessdata.fda.gov |
| Container, Specimen, Sterile | FMH | 1 | Manufacturer | accessdata.fda.gov |
| Device, General Purpose, Microbiology, Diagnostic | LIB | 1 | Manufacturer | accessdata.fda.gov |
| Device, Heat-Sealing | KSD | 1 | Manufacturer | accessdata.fda.gov |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | 1 | Manufacturer | accessdata.fda.gov |
| I.V. Start Kit | LRS | 2 | Manufacturer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Manufacturer | accessdata.fda.gov |
| Supplies, Blood-Bank | KSS | 1 | Manufacturer | accessdata.fda.gov |
| System, Blood Collection, Vacuum-Assisted, Manual | KST | 1 | Contract manufacturer | accessdata.fda.gov |
| Tourniquet, Nonpneumatic | GAX | 1 | Manufacturer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Manufacturer | accessdata.fda.gov |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 23, 2016 | K153472 | Quiver Laparoscopic Extendable | HAM | Substantially Equivalent | Itl Corporation Pty, Ltd. | accessdata.fda.gov |
| July 2, 2002 | K021941 | SAMPLOK LUER KIT | JKA | Substantially Equivalent | Itl Corporation Pty, Ltd. | accessdata.fda.gov |
| April 11, 2000 | K000777 | SAMPLOK | JKA | Substantially Equivalent | Itl Corporation Pty, Ltd. | accessdata.fda.gov |
| May 14, 1999 | K991404 | PLATYPUS AV FISTULA NEEDLE PROTECTOR (AVFNP) | FMI | Substantially Equivalent | Itl Corporation Pty, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Supplies, Blood-Bank
- All makers of Container, Specimen, Sterile
- All makers of Tray, Surgical, Instrument
- All makers of System, Blood Collection, Vacuum-Assisted, Manual
- All makers of Device, General Purpose, Microbiology, Diagnostic
- All makers of Device, Heat-Sealing
Updated June 23, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.