Ligamed® Australasia Pty Ltd is the exclusive distributor for all medical products produced by Ligamed® Medical ProdukteGmbh, the German company, within the Asian Pacific region. Included in their product list are the unique wound dressings Ligasano®White and Ligasano®Green.

Ligamed® Australasia Pty Ltd was formed in early 2009 to provide the Ligasano® opportunity to Australasia. There are close ties with Germany.

We have a dynamic team making up Ligamed® Australasia Pty Ltd. With over 20 years’ experience with Ligasano®.

Ligamed®Medical ProdukteGmbhwas formed in 1992 to distribute and market Ligasano®. Ligasano® is currently distributed in 18 countries throughout Europe, Africa and Australasian Region.

Ligamed®Medical ProdukteGmbhcarries the required quality assurances required for the design, development, manufacturing and distribution for polyurethane foam dressings for wound care as part of the Medical Device Directive.

DIN EN ISO 13485:2012 “medical devices – Quality management systems – requirements for regulatory purposes”

 

EC Certificate Directive 93/42/EEC, annex II

Ligasano® is included in the TGA ARTG (Australian Register of Therapeutic Goods) in both the sterile and unsterile forms.

Service, delivery and going the extra mile is the foundation to our business.  We have treated many wounds successfully where previous treatments have failed.

The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health, and is responsible for regulating therapeutic goods including prescription medicines, vaccines, sunscreens, vitamins and minerals,medical devices, blood and blood products.

 

Almost any product for which therapeutic claims are made must be entered in the Australian Register of Therapeutic Goods (ARTG) before it can be supplied in Australia.

UntitledIs an independent registrar for applicants within EU. As Notified Body 0481 in the non-active medical product sector, ecm is the independent contact for manufacturers in the health sector which have to prove that their products conform with specific EU directives. ecm performs for these manufacturers conformity assessment procedures in accordance with Directive 93/42/EC 2003/32/EC and certifies quality management systems in accordance with EN ISO 13485 and related standards (e.g. EN ISO 9001, EN ISO 15378). Our SERVICES section will tell you for which medical devices ecm is your partner for acquiring the CE label or appropriate certificates.