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Singapore HSA registration DE0509623

Terumo CAPIOX FX Advance

Singapore flagSingapore·CLASS B·TERUMO CORPORATION·Registered August 05, 2024
Device classification
Device Class
CLASS B
Medical Speciality Area
Cardiovascular
Registration information
Registration Number
DE0509623
Registration Date
August 05, 2024
Retention Due Date
August 04, 2025
Product description
The CAPIOX FX Advance is intended to be used during open heart surgical procedures requiring cardiopulmonary bypass for periods up to 6 hours.
Product Owner
Name
TERUMO CORPORATION
Short Name
TERUMO CORPORATION
Address
2-44-1, Hatagaya, Shibuya-ku, Tokyo, 151-0072, JAPAN
Registrant
Name
TERUMO ASIA HOLDINGS PTE LTD
Address
300 BEACH ROAD, THE CONCOURSE, #37-01, SINGAPORE 199555
Importer
Name
TERUMO ASIA HOLDINGS PTE LTD
Address
300 BEACH ROAD, CONCOURSE, THE, #37-01, SINGAPORE 199555
Model information
Model Name(s)
CAPIOX FX15 Advance CAPIOX FX15 Advance CAPIOX FX15 Advance CAPIOX FX15 Advance CAPIOX FX25 Advance CAPIOX FX25 Advance
Model Identifier(s)
CX*FX15RE30V CX*FX15RE40V CX*FX15RW30V CX*FX15RW40V CX*FX25REV CX*FX25RWV
About this record

Access comprehensive regulatory information for Terumo CAPIOX FX Advance in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509623 and owned by TERUMO CORPORATION. The device was registered on August 05, 2024.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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