Pure Global

STERIS Innowave PCF Sonic Irrigator - HSA Registration DE0505201

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.

Free Database
Powered by Pure Global AI
HSA Official Data
CLASS B
DE0505201
STERIS Innowave PCF Sonic Irrigator
HSA Registration Number: DE0505201
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
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.

Device 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 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