Summary for ARTG Entry:
Paragon Healthcare Pty Ltd - Transducer assembly, ultrasound, diagnostic, intracorporeal, vaginal
ARTG entry for
Medical Device Included Class IIa
Paragon Healthcare Pty Ltd
1 / 56 Norcal Road,NUNAWADING, VIC, 3131
ARTG Start Date
Medical Device Class IIa
- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,
Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations
2002 for relevant information.
- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal
offence; and civil penalties may apply.
B-K Medical ApS
Herlev, , 2730
1. Transducer assembly, ultrasound, diagnostic, intracorporeal, vaginal
Single Device Product
40771 Transducer assembly, ultrasound, diagnostic, intracorporeal, vaginal
An ultrasound transducer assembly specifically designed to be positioned within the vagina either
manually or under endoscopic guidance. It steers, focuses, and detects the ultrasound beam and resulting
echoes electronically. This ultrasound transducer is used with B-mode, M-mode, Doppler, Colour Doppler
(CD), and duplex (combination imaging, Doppler and/or colour flow) scanning capabilities. This device is
No Specific Conditions included on Record
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Produced at 10.11.2017 at 02:18:20 AEDT
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