Explore registrations, market listings and compliance documents.
6markets with source documents
3markets with registration in progress
20source documents reviewed
UNITED STATESRealNow™ · FDA 510(k)CT perfusion · Identifier withheld
Registrations in Progress
Company-reported workstreams · September 2026 update.
Malaysia
Registration in progress
YIWEI’s September 2026 overseas presentation lists registration in progress, with a year-end 2026 target. Approval and certificate details have not been supplied.
Singapore
Registration in progress
YIWEI’s September 2026 overseas presentation lists registration in progress, with a year-end 2026 target. Approval and certificate details have not been supplied.
Indonesia
Registration in progress
YIWEI’s September 2026 overseas presentation lists registration in progress, with a year-end 2026 target. Approval and certificate details have not been supplied.
18 documented recordsSource review · October 2026
United StatesFDA 510(k) clearance
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EuropeHistorical CE compliance documentation
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ChinaMedical device registration
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ThailandListed medical device certificate
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Hong KongMDACS certificate of listing
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BrazilICC conformity certificate
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Showing 6 of 18 records
SUPPORTING DOCUMENTATION
Virtual Brain · Third-party Record
Third-party establishment statement · No device clearance established.
Scope Follows the Product
Each record applies to its named device, version and intended use. Registration, listing and conformity documentation follow different regulatory routes.