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Body-orifice ultrasound imaging system transducer cover, basic, sterile - ARTG 431911

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 registered under ARTG number 431911 and sponsored by Meditron Pty Ltd, manufactured by Civco Medical Instruments Co Inc DBA CIVCO and CIVCO Medical Solutions in United States of America. The device registration started on December 22, 2023.

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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TGA ARTG Official Data
Class IIa
ARTG 431911
Class IIa
Body-orifice ultrasound imaging system transducer cover, basic, sterile
ARTG ID: 431911
Good Name: Meditron Pty Ltd - Body-orifice ultrasound imaging system transducer cover, basic, sterile
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Intended Purpose

Protective cover or sheath placed over diagnostic transducer/probe/scanhead instruments. The cover allows use of the transducer in scanning and needle guided procedures for endocavity and transesophageal 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 (both sterile and non-sterile covers). The cover also provides a means for maintenance of a sterile field (sterile covers only).

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
431911
Start Date
December 22, 2023
Effective Date
December 22, 2023
Sponsor
Manufacturer
Country
United States of America
Address
102 First Street South, Kalona, IA, 52247