Summary for ARTG Entry:
Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Perfadex solution - Organ preservation solution
ARTG entry for
Medical Device Included Class III
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 III
- 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.
Xvivo Perfusion AB
Massans gata 10
, Goteborg, SE-412 51
1. Perfadex solution - Organ preservation solution
Single Device Product
18004 Organ preservation solution
Perfadex solution for organ perfusion is a clear, sterile, non-pyrogenic colloid based extracellular low
potassium dextran solution primarily for rapid cooling, perfusion and storage of lungs in connection with
Intended for flushing, storage and transportation of isolated lungs after removal from the donor in
preparation for eventual transplantation into a recipient
Nil variant (as 1 device) Nil
No Specific Conditions included on Record
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Produced at 02.12.2017 at 04:54:49 AEDT
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