Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Med-Ideology Pty Ltd - Scalp cooling system
ARTG entry for
Medical Device Included Class IIa
Med-Ideology Pty Ltd
PO Box 510,Baulkham Hills, NSW, 2153
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.
Lund, Sweden, 226 60
1. Scalp cooling system
Single Device Product
62231 Scalp cooling system
Scalp cooling is intended to constrict blood vessels in the scalp, which reduces the amount of
chemotherapy that reaches cells in the hair follicles. The cold temperature also decreases the activity of
the hair follicles and slows down cell division, making them less affected by chemotherapy. The combined
actions reduce the effect chemotherapy has on the cells, which may prevent / minimise hair loss.
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Produced at 02.11.2019 at 05:02:05 AEDT
This is not an ARTG Certificate document.
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