YIWEI MEDICAL / INTERNATIONAL PRESENCE

Global Reach
Product-Specific Records

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.