Directory of TGA-Approved Bioimpedance & Body-Composition Analysers in Australia (2026)
This directory gives procurement teams a starting list of TGA ARTG entries for bioimpedance and body-composition analysers in Australia, plus a Canada MDALL comparison set for multi-market buyers. Asaptic is an independent sourcing partner; listings are compiled from public registries — verify the current record before procurement.
Australia / TGA ARTG
| Brand | Model | Sponsor | ARTG ID | Class | Notes |
|---|---|---|---|---|---|
| ImpediMed | Body Composition Analyser | Impedimed Pty Ltd | 134672 | IIa | BIA; verify on live registry |
| ImpediMed | SOZO Pro | ImpediMed Ltd | 447313 | IIa | BIA (2024); verify on live registry |
| Tanita | Body fat/lean ratio analyser | W W Wedderburn Pty Ltd | 142294 | IIa | BIA; verify on live registry |
| Maltron | Bioscan | Hoyland Medical Pty Ltd | 425350 | IIa | BIA; verify on live registry |
| Selvas/Evolt | Evolt 360 | Evolt IoH Pty Ltd | 341529 | IIa | BIA; verify on live registry |
| InBody | InBody 570 | InBody Body Composition Analysers Pty Ltd | 207297 | IIa | verify on live registry |
| Cosmed | Densitometry body composition | Cosmed Asia-Pacific | 218576 | Im | NOTE: DEXA, not BIA; verify on live registry |
Confirm each at tga.gov.au/resources/artg/<id>. Verify on the live registry before procurement.
Canada / Health Canada MDALL
| Manufacturer | Device | MDALL Licence | Class | Origin |
|---|---|---|---|---|
| InBody | Body Composition Analyzers | 84898 | II | Korea |
| Conmo Electronic | Body Composition Analyzer | 110203 (also 101065) | II | China |
| Seca | Seca 525 | 96711 (also 90107, 101530) | II | Germany |
| Tanita | Segmental Body Composition Analyzer | 65182 | II | Japan |
| Omron | Body Fat Analyzer | 34417 | II | Japan |
| Blay Scientific | Body Composition Analyzer | 110801 | II | Canada |
| Fresenius | BCM (dialysis fluid) | 76685 | II | Germany |
Search mdall-limh.hc-sc.gc.ca by licence number, manufacturer, and device name. Verify on the live registry before procurement.
How buyers verify these
For Australia, use the TGA ARTG public resource at tga.gov.au/resources/artg. Enter the ARTG ID, then confirm the sponsor, device name, class, public summary, and whether the record is still active. Where a record covers a device family, ask the sponsor to identify the exact model and configuration within scope.
For Canada, use Health Canada's MDALL search at mdall-limh.hc-sc.gc.ca. Search by licence number and manufacturer, then confirm the current status, device class, company name, and device description. Put screenshots or exported search results in the procurement file, because registry records can change after supplier qualification.
For device procurement workflows, connect registry verification with the clinical devices sourcing process and the compliance matrix. A registry match is one input; it does not replace intended-use review, ISO 13485 evidence, IEC 60601-1 safety documentation, post-market support checks, or clinical validation review.
Frequently asked questions
Does an ARTG entry prove a body-composition analyser is approved for every clinical use?
No. Buyers should verify the current ARTG record, sponsor, model scope, device class, and intended purpose before procurement. An entry may cover a family of devices or a narrower indication than the buyer's intended clinical workflow.
How do buyers confirm a TGA ARTG record?
Use the TGA ARTG public resource at tga.gov.au/resources/artg and check the exact ARTG ID, sponsor name, device description, class, and status. For the IDs in this directory, confirm each at tga.gov.au/resources/artg/<id>.
How do buyers confirm a Health Canada MDALL record?
Use Health Canada's MDALL search at mdall-limh.hc-sc.gc.ca and confirm the current licence number, manufacturer, device name, class, and active status before using the record in a procurement file.
Are DEXA and BIA body-composition devices interchangeable?
No. DEXA and BIA use different measurement methods and regulatory records should not be treated as interchangeable. This directory flags the Cosmed densitometry body composition entry as DEXA, not BIA.
澳大利亚TGA批准生物电阻抗与体成分分析仪目录（2026）
本页为采购团队提供澳大利亚TGA ARTG与加拿大Health Canada MDALL公开记录的起始核查目录。Asaptic is an independent sourcing partner; listings are compiled from public registries — verify the current record before procurement.
采购前请在TGA ARTG或Health Canada MDALL实时数据库中核实具体记录、保荐人/制造商、型号范围、类别、状态与适用用途。本页仅作为筛选和引用辅助，不替代法律或监管意见。
澳大利亞TGA批准生物電阻抗與體成分分析儀目錄（2026）
本頁為採購團隊提供澳大利亞TGA ARTG與加拿大Health Canada MDALL公開記錄的起始核查目錄。Asaptic is an independent sourcing partner; listings are compiled from public registries — verify the current record before procurement.
採購前請在TGA ARTG或Health Canada MDALL即時數據庫中核實具體記錄、保薦人/製造商、型號範圍、類別、狀態與適用用途。本頁僅作為篩選和引用輔助，不替代法律或監管意見。