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KOREA MFDS approved
- Class B approved by the Vietnam Ministry of Health
- Class C approved by the Indonesia Ministry of Health
- Approved by Hong Kong MDD as Class II
- Approved by Malaysia MDA as Class B
- Notified to Brazil ANVISA as Class II
- Notified to Philippines FDA as Class B
- Cleared by UAE MOHAP as Medical Device
- Approved by Singapore HSA as Class B
- Approved by Saudi Arabia SFDA as Class B
- Approved by Thailand TFDA as Class 2
- Included in the ARTG entry by Australian TGA as Class IIa
- Certified by Registered Certified Body in Japan as Class II
*SwiftMR’s future availability in other regions cannot be guaranteed.
Any updates in future regulatory status will be available on our website.