Summary for ARTG Entry:
Medical Industries Australia - MedGyn Cryotherapy System - Cryosurgical unit, general-purpose
ARTG entry for
Medical Device Included Class IIa
Medical Industries Australia
512 Creek Street,ALBURY, NSW, 2640
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.
Medgyn Products Inc
100 W Industrial Rd
Addison, ILLINOIS, 60101
United States Of America
1. MedGyn Cryotherapy System - Cryosurgical unit, general-purpose
Medical device system
11067 Cryosurgical unit, general-purpose
This is a device that is intended to be used for all cryogenic procedures. It utilises liquid or gaseous
refrigerant to withdraw heat through direct application of cryogen or the cryogen cooled probe. This device
has applications for Dermatology, oral surgery, gynaecology, urology, otolaryngology or proctology.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 08:03:58 AEDT
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