The iMOST platform is manufactured in Shanghai, China, within ISO 13485–certified facilities. These sites have successfully undergone rigorous audits by global IVD partners.
Participation in external QC programs needs to be evaluated. Please note that traditional QC materials may not always be compatible with the system due to unique differences in measurement principles.
The response protocol depends on the specific error type. While troubleshooting can often be conducted remotely, certain situations may necessitate a service or a formal device inspection.
Yes. Under current CE-mark approvals, POCT is explicitly included in the intended use. This supports deployment in decentralized and near-patient settings.
iMOST is currently obtaining PST-specific approvals in select regions. For CE-marked regions, the platform is currently positioned for POCT (professional use) rather than PST. However, preparation for future PST support is underway. Always refer to local labeling/IFU for defined users and settings.
The iMOST platform (specifically iMOST-L and iMOST-U) carries CE-IVD / IVDR marking. It is registered or deployed across multiple regions, including the EU and parts of Asia. Manufacturing occurs in ISO 13485–certified facilities that have been audited by global IVD partners.
Troubleshooting is typically initiated remotely. If hardware service is necessary, support is coordinated through the local distributor or an authorized service partner, adhering to the established service agreement.
The analyzer is deemed out of warranty under the following conditions:
Expiration: The standard warranty period has concluded
Usage Limits: The device has exceeded the specified warranty test-volume limit as defined in commercial terms
Misuse: Damage or malfunction occurs due to unauthorized modification, improper handling, misuse, or operation outside of specified environmental conditions
After the warranty period ends, Essenlix provides paid technical support, including spare parts and repair or replacement options. Specific duration and coverage details are governed by your applicable commercial agreement and warranty policy.
Troubleshooting is typically initiated remotely. If hardware service is necessary, support is coordinated through the local distributor or an authorized service partner, adhering to the established service agreement.
The analyzer is deemed out of warranty under the following conditions:
Expiration: The standard warranty period has concluded
Usage Limits: The device has exceeded the specified warranty test-volume limit as defined in commercial terms
Misuse: Damage or malfunction occurs due to unauthorized modification, improper handling, misuse, or operation outside of specified environmental conditions
After the warranty period ends, Essenlix provides paid technical support, including spare parts and repair or replacement options. Specific duration and coverage details are governed by your applicable commercial agreement and warranty policy.
