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NIPRO GUIDEPLUS II Guide Extension Catheter - HSA Registration DE0504811

Access comprehensive regulatory information for NIPRO GUIDEPLUS II Guide Extension Catheter in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0504811 and owned by NIPRO CORPORATION. The device was registered on August 12, 2020.

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 D
DE0504811
NIPRO GUIDEPLUS II Guide Extension Catheter
HSA Registration Number: DE0504811
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Product Description

This device is inserted into coronary arteries and used to guide interventional devices, etc. to affected areas in coronary arteries during procedures such as percutaneous transluminal coronary angioplasty. Notably, this product is placed in front of affected areas that are difficult for interventional devices to reach, and then used to support an interventional device.

Device Classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0504811
Registration Date
August 12, 2020
Change Notification Approval Date
December 05, 2024
Retention Due Date
August 11, 2025
Product Owner
Short Name
NIPRO CORPORATION
Address
3-26, Senriokashinmachi, Settu, Osaka, 566-8510, JAPAN
Registrant
Address
36 JALAN TUKANG, SINGAPORE 619266
Importer
Address
36 JALAN TUKANG, SINGAPORE 619266
Model Information
Model Name(s)
GUIDEPLUS II EL Guide Extension Catheter 6Fr GUIDEPLUS II ST Guide Extension Catheter 6Fr
Model Identifier(s)
GUIDEPLUS 2 EL INT GUIDEPLUS 2 ST INT