Singapore HSA registration DE0505218
ASAHI PTCA Guide Wire ASAHI Gladius
Singapore·CLASS D·Asahi Intecc Co., Ltd·Registered December 07, 2020Device classification
- Device Class
- CLASS D
- Medical Speciality Area
- Cardiovascular
Registration information
- Registration Number
- DE0505218
- Registration Date
- December 07, 2020
- Change Notification Approval Date
- August 20, 2024
- Retention Due Date
- December 06, 2025
Product description
ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA). The ASAHI PTCA Guide Wires are 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 Gladius MG14 190cm Pre-shape ASAHI Gladius MG14 190cm Straight ASAHI Gladius MG14 ES 190cm Pre-shape ASAHI Gladius MG14 ES 190cm Straight ASAHI Gladius EX14 200cm Pre-shape ASAHI Gladius EX14 200cm Straight ASAHI Gladius MG14 300cm Pre-shape ASAHI Gladius MG14 300cm Straight ASAHI Gladius MG14 ES 300cm Pre-shape ASAHI Gladius MG14 ES 300cm Straight ASAHI Gladius EX14 300cm Pre-shape ASAHI Gladius EX14 300cm Straight
- Model Identifier(s)
- AP14R023P AP14R023S AP14R024P AP14R024S AP14R025P AP14R025S AP14R323P AP14R323S AP14R324P AP14R324S AP14R325P AP14R325S
About this record
Access comprehensive regulatory information for ASAHI PTCA Guide Wire ASAHI Gladius in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0505218 and owned by Asahi Intecc Co., Ltd. The device was registered on December 07, 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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS D