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Regulatory Disclaimer

Important regulatory information for healthcare professionals.

Template — pending legal review

This document is a structural placeholder. The legal text below must be reviewed and adapted by qualified counsel before the site goes to production. Replace each section's body with the reviewed copy before public launch.

Last updated: 2026-05-15

1. Intended use

Products described on this site are medical devices intended for use by, or under the direction of, a qualified healthcare professional. They are NOT intended for self-diagnosis or self-treatment by lay users.

2. Read the IFU

Each device ships with its own Instructions For Use (IFU), indications, contraindications, warnings, and precautions. The IFU is the authoritative source of information for clinical use. Marketing content on this website is a summary and does NOT replace the IFU.

3. Regulatory status

Regulatory approvals, clearances, and certifications vary by country and by device. Availability of any specific product in your region depends on the local regulatory status; please contact us to confirm before placing an order. CE marking, CDSCO registration (India), and other approvals appear on the relevant device's product page where applicable.

4. Adverse-event reporting

If you become aware of an adverse event, malfunction, or quality complaint involving any device manufactured by Integrated Meditech Solutions Pvt. Ltd., report it to us promptly via the contact channels at the bottom of this page. Reporting also remains your obligation to your local regulatory authority where applicable.

5. Off-label / non-approved use

Use of a device outside the conditions described in the IFU, or in a country where the device is not approved, is the sole responsibility of the prescribing healthcare professional.

6. Pictures are illustrative

Photographs, renderings, and screenshots on this website are for illustration only. Actual device appearance, packaging, and accessory configuration may vary by region and SKU.

Questions about this document

Contact us by email: [email protected]