FDA Registration
Active
🇲🇾 Malaysia
ITL ASIA PACIFIC SDN BHD
Reg #: 3003895930
·
FEI: 3011649541
·
Expires 2026
Products
12
Proprietary Names
37
Establishment Types
2
Classifications
12
Registration Details
- Registration Name
- ITL ASIA PACIFIC SDN BHD
- Registration Number
- 3003895930
- FEI Number
- 3011649541
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Plot 17B, Lorong Bemban 2, Bemban Industrial Estate
- City
- Batu Gajah Perak
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K021941
Owner / Operator
- Firm Name
- ITL Health Group
- Operator Number
- 9033436
- Address
- Level 3, 59 Wentworth Ave
- City
- Kingston
- State
- Australian Capital Territory
- Postal Code
- 2604
- Country
- AU
- Correspondent
- Narinder Kanda
US Agent
- Business Name
- REGULATORY COMPLIANCE EXPERTS, INC.
- Contact Name
- Susan Finneran
- Address
- 186 Old Farm Rd.
- City
- Abington
- State
- MA
- ZIP
- 02351
- Country
- US
- [email protected]
- Phone
- 781 6640074
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2007-11-09 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2007-11-09 |
| Device, Heat-Sealing | KSD | Class 1 | Hematology | No | 2007-03-12 |
| Apparatus, Electrosurgical | HAM | Class 2 | General, Plastic Surgery | No | 2016-07-08 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2026-06-16 |
| I.V. Start Kit | LRS | Class 2 | General Hospital | No | 2023-05-09 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2021-12-11 |
| Supplies, Blood-Bank | KSS | Class 1 | Hematology | No | 2007-12-07 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2016-07-25 |
| Device, General Purpose, Microbiology, Diagnostic | LIB | Class 1 | Microbiology | No | 2008-07-11 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2008-08-06 |
| System, Blood Collection, Vacuum-Assisted, Manual | KST | Class 1 | Hematology | No | 2017-08-22 |
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
A100723
A100722
A100727
A100720
A100724
A100730
C100400
6R4011
A100100
A100150
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)