iHarvest Smart Laser Helmet — regulatory compliance and market authorization details.
| European Union (27 member states) | Authorized — CE Mark EU MDR 2017/745 Class IIa certified. Free movement across EU/EEA. |
| United Kingdom (post-Brexit) | Authorized — UKCA Mark UK MDR 2002 compliance. UKCA marking applies. |
| Malaysia | Authorized Manufactured in Malaysia. MDA registration may apply for domestic sale. |
| Singapore | Authorized HSA Health Products (Medical Device) Regulations apply. |
| Gulf Cooperation Council (UAE, KSA, etc.) | Authorized CE mark recognized. Some GCC countries require additional local registration. |
| China | Check local requirements NMPA registration required for medical device sale. Contact for guidance. |
| Australia | Authorized — TGA included CE mark recognized under ARTG inclusion pathway. |
| United States | NOT Authorized iHarvest is not FDA-cleared and is not authorized for sale or use in the United States. |
The CE mark on iHarvest signifies that the device meets the essential safety and performance requirements of the EU Medical Device Regulation (EU MDR 2017/745). Specifically:
iHarvest is CE-certified for markets requiring CE marking. The device has not been reviewed or cleared by the US Food and Drug Administration (FDA). The device is not authorized for sale or distribution in the United States.
This device is not intended to diagnose, treat, cure, or prevent any disease. Individual results may vary. Users should follow the prescribed treatment protocol and consult a qualified healthcare professional for any medical concerns.
| Manufacturer | T-Biomax Sdn. Bhd. |
| Country of Origin | Malaysia |
| Device Name | iHarvest Smart Laser Helmet |
| Device Classification | Class IIa (EU MDR 2017/745) |
| Certificate Number | Contact for verification |
| Certification Valid | Through May 2029 |