Singapore HSA registration DE0505201
STERIS Innowave PCF Sonic Irrigator
Singapore·CLASS B·Steris Corporation·Registered December 03, 2020Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0505201
- Registration Date
- December 03, 2020
- Change Notification Approval Date
- August 01, 2023
- Retention Due Date
- December 02, 2025
Product description
The InnoWave PCF Sonic Irrigator is a high-pressure flushing ultrasonic water disinfector. It is intended to provide cleaning and intermediate-level thermal disinfection of surgical instruments, including complex lumen/cannulated devices, such as robotic surgical instruments. Cleaning is achieved through a combination of sonic irrigation (ultrasonic cavitation), and lumen flushing to remove debris from instruments placed in the wash tank.
Product Owner
- Short Name
- Steris Corporation
- Address
- 5960 Heisley Road, Mentor, Ohio 44060, UNITED STATES
Registrant
- Address
- 29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #04-01, SINGAPORE 138565
Importer
- Address
- 29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #04-01, SINGAPORE 138565
Model information
- Model Name(s)
- Innowave PCF Sonic Irrigator
- Model Identifier(s)
- IW531055NPR
About this record
Access comprehensive regulatory information for STERIS Innowave PCF Sonic Irrigator in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0505201 and owned by Steris Corporation. The device was registered on December 03, 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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