Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Profile Medical Devices Pty Ltd - Non-vascular guidewire
ARTG entry for
Medical Device Included Class IIa
Profile Medical Devices Pty Ltd
PO Box 66,Edgecliff, NSW, 2027
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.
Uromed Kurt Drews KG
, Oststeinbek, 22113
1. Non-vascular guidewire
Single Device Product
45623 Non-vascular guidewire
Flexible guidance instrument for the application or exchange of urological catheters.
No Specific Conditions included on Record
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Produced at 03.11.2017 at 02:14:06 AEDT
This is not an ARTG Certificate document.
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