Regulatory
Regulatory status of the Lifemotion ECMO system
For a hospital procuring an ECMO platform, regulatory status is foundational. Below is the current status for Australia (TGA / ARTG), New Zealand (WAND) and CE Mark (MDR). Always confirm the current entry details and approved intended purpose against the official records and the product's Instructions for Use (IFU).
Australia — TGA / ARTG
The Lifemotion ECMO system holds four current entries on the Australian Register of Therapeutic Goods (ARTG), covering each core component of the circuit.
| Component | Model | ARTG entry | Official TGA record |
|---|---|---|---|
| ECMO Console | LM-ECMO-1000 | 528964 | View ARTG 528964 ↗ |
| Disposable Membrane Oxygenator | LM-BGEA-1000 | 528771 | View ARTG 528771 ↗ |
| Disposable Centrifugal Pump Head | LM-PH-1000 | 528772 | View ARTG 528772 ↗ |
| ECMO Sets | LM-TPS-1000 / 1000L / 1500L | 528773 | View ARTG 528773 ↗ |
Inclusion on the ARTG means each product is an included/current entry on the TGA register for supply in Australia, within the applicable entry and approved intended purpose. Legal sponsor: SASS Biomedical Engineering Services t/a OHM Biomedical Engineering Services.
New Zealand — WAND
The Lifemotion ECMO system is notified / included in the WAND notification database (Web Assisted Notification of Devices) administered by Medsafe. WAND is a notification database, not an approval system — this is not a statement of Medsafe approval or clearance. See the Medsafe WAND information ↗.
CE Mark (MDR)
The Lifemotion ECMO system also holds CE Mark certification under the European Medical Device Regulation (MDR).
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