Singapore HSA registration DE0504811
NIPRO GUIDEPLUS II Guide Extension Catheter
Singapore·CLASS D·NIPRO CORPORATION·Registered August 12, 2020Device 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 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.
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
About this record
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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