Pure Global AI
HSA · registration DE0509623

Terumo CAPIOX FX Advance

SingaporeCardiovascularClass BTERUMO CORPORATION
Verified
Official record identity
Registration number
DE0509623
Model name
CAPIOX FX15 Advance; CAPIOX FX15 Advance; CAPIOX FX15 Advance; CAPIOX FX15 Advance; CAPIOX FX25 Advance; CAPIOX FX25 Advance
Model identifier
CX*FX15RE30V; CX*FX15RE40V; CX*FX15RW30V; CX*FX15RW40V; CX*FX25REV; CX*FX25RWV
Registration date
August 05, 2024
Classification
Risk class
Class B
Official value: CLASS B
Published category
Cardiovascular
View exact category matches →
Published parties
Product owner
TERUMO CORPORATION
Registrant / registration holder
TERUMO ASIA HOLDINGS PTE. LTD.
Official description

The CAPIOX FX Advance is intended to be used during open heart surgical procedures requiring cardiopulmonary bypass for periods up to 6 hours.

Additional source fields
Product owner address
2-44-1, Hatagaya, Shibuya-ku, Tokyo, 151-0072, Japan
Registrant address
300 BEACH ROAD, #37-01, THE CONCOURSE, Singapore 199555
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.