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Terumo Progreat λ - HSA Registration DE0506045

Access comprehensive regulatory information for Terumo Progreat λ in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0506045 and owned by Terumo Clinical Supply Co., Ltd.. The device was registered on August 04, 2021.

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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CLASS B
DE0506045
Terumo Progreat λ
HSA Registration Number: DE0506045
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Product Description

The Progreat λ is intended for use in the peripheral vasculature for the infusion of contrast media, drugs and embolic materials in intravascular therapy. The indications of the Progreat λ include but are not limited to feeding arteries of hepatocellular carcinoma, arteriovenous malformations and internal bleeding.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0506045
Registration Date
August 04, 2021
Change Notification Approval Date
November 18, 2024
Retention Due Date
August 03, 2025
Product Owner
Short Name
Terumo Clinical Supply Co., Ltd.
Address
3, Kawashima-Takehayamachi, Kakamigahara, Gifu, 501-6024, JAPAN
Registrant
Address
300 BEACH ROAD, THE CONCOURSE, #37-01, SINGAPORE 199555
Importer
Address
300 BEACH ROAD, CONCOURSE, THE, #37-01, SINGAPORE 199555 300 BEACH ROAD, CONCOURSE, THE, #33-06, SINGAPORE 199555
Model Information
Model Name(s)
Progreat λ Progreat λ Progreat λ Progreat λ Progreat λ Progreat λ Progreat λ Progreat λ Progreat λ Progreat λ Progreat λ Progreat λ Progreat λ Progreat λ Progreat λ Progreat λ Progreat λ Progreat λ Progreat λ Progreat λ Progreat λ Progreat λ Progreat λ Progreat λ Progreat λ Progreat λ Progreat λ Progreat λ Progreat λ Progreat λ
Model Identifier(s)
CC-M1711AN CC-M1711DN CC-M1711SN CC-M1713AN CC-M1713DN CC-M1713SN CC-M1715AN CC-M1715DN CC-M1715SN CC-M1716AN CC-M1716DN CC-M1716SN CC-M1717AN CC-M1717DN CC-M1717SN CC-M1911AN CC-M1911DN CC-M1911SN CC-M1913AN CC-M1913DN CC-M1913SN CC-M1915AN CC-M1915DN CC-M1915SN CC-M1916AN CC-M1916DN CC-M1916SN CC-M1917AN CC-M1917DN CC-M1917SN