Extract to table

subsidiaries of foreign medical device manufacturers and carries with it distinct regulatory obligations that must be carefully coordinated

The registration and listing obligations discussed herein must be completed in coordination with these milestones, as described more fully in Section IX below

SBI must register as a domestic establishment with FDA prior to commencing commercial distribution of the Solstice Lumina™ CGM System in the United States

Registration must be submitted electronically through FDA's FURLS/DRLM portal

SBD, as the foreign manufacturer of the Lumina CGM System at its facility located at Unit 14, Liffey Innovation Park, Chapelizod, Dublin D20 FX72, Ireland, must separately register as a foreign establishment with FDA

agent serves as the point of contact between FDA and the foreign establishment for all communications concerning device listing, registration, and related regulatory matters, and must be a real person who is accessible during normal business hours — the role cannot be fulfilled by a mailbox, answering machine, or answering service