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FDA 510(k) 承認
大韓民国食品医薬品安全処への届出 ・承認獲得済み



- 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
*SwiftMR の可用性は、今後他の地域でも保障するものではありません。 今後規制状況に関するすべての更新内容は、弊社のホームページでご確認いただけます。