Summary for ARTG Entry:
Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Surgical procedure kit, orthopaedic, bone cement
ARTG entry for
Medical Device Included Class IIa
Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Level 20 Tower II Darling Park 201 Sussex Street,SYDNEY, NSW, 2000
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.
Via Andrea Doria 6
Sommacampagna,, Verona, 37066
1. Surgical procedure kit, orthopaedic, bone cement preparation/delivery
Single Device Product
45253 Orthopaedic cement preparation/delivery kit
The sterile and single-use device is intended for the extrusion of acrylic resins or bone void fillers prepared
with a Tecres mixing device, named Shakit. The device is composed of a plastic syringe with luer-lok
connection and a scraper ring, a handle, an extrusion screw, and a stainless steel delivery cannula with
No Specific Conditions included on Record
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Produced at 02.12.2017 at 04:29:36 AEDT
This is not an ARTG Certificate document.
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