Australia TGA ARTG recordBody-orifice ultrasound imaging system transducer cover, basic, sterile
Australia TGA ARTG Registered Device · Meditron Pty Ltd · Civco Medical Instruments Co Inc DBA CIVCO and CIVCO Medical Solutions · Class IIa · Started December 22, 2023
Good Name: Meditron Pty Ltd - Body-orifice ultrasound imaging system transducer cover, basic, sterile
- Risk Class
- Class IIa
- Product Type
- Single Device Product
- ARTG Category
- General
- Start Date
- December 22, 2023
- Effective Date
- December 22, 2023
- Name
- Meditron Pty Ltd
- Country
- United States of America
- Address
- 102 First Street South, Kalona, IA, 52247
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).
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 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.