Summary for ARTG Entry:
10 Seas Consulting Pty Ltd T/a Videra Surgical & Diagnostics - Colposcope
ARTG entry for
Medical Device Included Class IIa
10 Seas Consulting Pty Ltd T/a Videra Surgical & Diagnostics
PO Box 371,The Junction, NSW, 2291
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.
The MedTECH Centre Rutherford House
Pencroft Way Manchester Science Park
Manchester, , M15 6SZ
Medical device system
The ZedScan is intended to be used as an adjunct to colposcopy in women suspected of having cervical
neoplasia and will improve the accuracy of colposcopy for the detection of High-Grade Cervical
Intraepithelial Neoplasia (HG-CIN; CIN2+).
No Specific Conditions included on Record
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Produced at 02.12.2017 at 04:25:04 AEDT
This is not an ARTG Certificate document.
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