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Body-orifice ultrasound imaging system transducer cover, basic, sterile

Australia TGA ARTG Registered Device · RQSolutions Medical Devices Distribution Support · Civco Medical Instruments Co Inc DBA CIVCO and CIVCO Medical Solutions · Class IIa · Started May 14, 2024

Good Name: RQSolutions Medical Devices Distribution Support - Body-orifice ultrasound imaging system transducer cover, basic, sterile

Device classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration information
Start Date
May 14, 2024
Effective Date
May 14, 2024
Sponsor
Manufacturer
Country
United States of America
Address
102 First Street South, Kalona, IA, 52247
Intended purpose

Protective cover or sheath placed over diagnostic ultrasound transducer/probe/scanhead instruments. The cover allows use of the transducer in scanning and needle guided procedures for body surface, endocavity, and intra-operative diagnostic ultrasound, while helping to prevent transfer of microorganisms, body fluids, and particulate material to the patient and healthcare worker during reuse of the transducer

About this record

Access comprehensive regulatory information for Body-orifice ultrasound imaging system transducer cover, basic, sterile in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by RQSolutions Medical Devices Distribution Support, manufactured by Civco Medical Instruments Co Inc DBA CIVCO and CIVCO Medical Solutions in United States of America. The device registration started on May 14, 2024.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.

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