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Singapore HSA registration DE0501555

Terumo Occlusafe Temporary Occlusion Balloon Microcatheter

Singapore flagSingapore·CLASS D·Terumo Clinical Supply Co., Ltd.·Registered April 23, 2018
Device classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration information
Registration Number
DE0501555
Registration Date
April 23, 2018
Change Notification Approval Date
August 21, 2024
Retention Due Date
April 22, 2026
Product description
The Occlusafe is intended for the following: For use in the peripheral vasculature where temporary occlusion is desired. It provides temporary vascular occlusion which is useful in selectively stopping or controlling blood flow. For use in the peripheral vasculature for the infusion of contrast media, drugs and embolic materials. The indication of the Occlusafe includes, but is not limited to, feeding arteries of tumour/hyperplasia, haemorrhage, aneurysm, varicose vein and arteriovenous malformations/ arteriovenous fistulas.
Product Owner
Name
Terumo Clinical Supply Co., Ltd.
Short Name
Terumo Clinical Supply Co., Ltd.
Address
3, Kawashima-Takehayamachi, Kakamigahara, Gifu, 501-6024, 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 TERUMO SINGAPORE PTE LTD
Address
300 BEACH ROAD, CONCOURSE, THE, #37-01, SINGAPORE 199555 300 BEACH ROAD, CONCOURSE, THE, #33-06, SINGAPORE 199555
Model information
Model Name(s)
Occlusafe Occlusafe Occlusafe
Model Identifier(s)
OB*T41140N OB*T41340N OB*T41540N
About this record

Access comprehensive regulatory information for Terumo Occlusafe Temporary Occlusion Balloon Microcatheter in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0501555 and owned by Terumo Clinical Supply Co., Ltd.. The device was registered on April 23, 2018.

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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS D