Singapore HSA registration DE0507469
ASAHI Gaia Next PCI Guide Wire
Singapore·CLASS D·Asahi Intecc Co., Ltd·Registered November 10, 2022Device classification
- Device Class
- CLASS D
- Medical Speciality Area
- Cardiovascular
Registration information
- Registration Number
- DE0507469
- Registration Date
- November 10, 2022
- Change Notification Approval Date
- August 20, 2024
- Retention Due Date
- November 09, 2025
Product description
This guide wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous coronary intervention (PCI) and percutaneous transluminal angioplasty (PTA). This guide wire is not intended for use in the neurovasculature.
Product Owner
- Short Name
- Asahi Intecc Co., Ltd
- Address
- 3-100 Akatsuki-cho, Seto, Aichi 489-0071, JAPAN
Registrant
- Address
- 133 CECIL STREET, KECK SENG TOWER, #16-01B, SINGAPORE 069535
Importer
- Address
- 12A JALAN AMPAS, BALESTIER WAREHOUSE BUILDING, #03-03, SINGAPORE 329516 133 CECIL STREET, KECK SENG TOWER, #16-01B, SINGAPORE 069535
Model information
- Model Name(s)
- ASAHI Gaia Next 1 PCI Guide Wire 190cm Pre-shape ASAHI Gaia Next 2 PCI Guide Wire 190cm Pre-shape ASAHI Gaia Next 3 PCI Guide Wire 190cm Pre-shape ASAHI Gaia Next 1 PCI Guide Wire 235cm Pre-shape ASAHI Gaia Next 2 PCI Guide Wire 235cm Pre-shape ASAHI Gaia Next 3 PCI Guide Wire 235cm Pre-shape ASAHI Gaia Next 1 PCI Guide Wire 300cm Pre-shape ASAHI Gaia Next 2 PCI Guide Wire 300cm Pre-shape ASAHI Gaia Next 3 PCI Guide Wire 300cm Pre-shape
- Model Identifier(s)
- AH14R019P AH14R020P AH14R021P AH14R219P AH14R220P AH14R221P AH14R319P AH14R320P AH14R321P
About this record
Access comprehensive regulatory information for ASAHI Gaia Next PCI Guide Wire in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0507469 and owned by Asahi Intecc Co., Ltd. The device was registered on November 10, 2022.
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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