Legal compliance

Regulatory status

Products in the Alpro range are listed on the Australian Register of Therapeutic Goods (ARTG) where required — registration numbers are stated on each product page and in its Product Information (for example Alpron/Bilpron ARTG 226413, BIB forte ARTG 167778, PlastiSept eco ARTG 164389).

i3 sterile filters are CE-marked Class 1 medical devices under the EU Medical Device Regulation (MDR).

Documentation

A current Product Information sheet and, where applicable, a Safety Data Sheet is available for every product — most directly on this site, the remainder on request. Safety Data Sheets follow the GHS format for Australia.

Standards alignment

The range supports documented reprocessing and infection-control workflows consistent with AS 5369 (reprocessing of reusable medical devices). The mapping of specific standard clauses to a given surgery must be confirmed with Biodegree and your compliance adviser — content on this site frames audit readiness and is not a certification.

Advertising and claims

All efficacy and contact-time claims on this site are manufacturer/study-stated and footnoted to their source. Studies with industry funding are disclosed as such.

Company details

Biodegree — exclusive ANZ distributor of Alpro Medical · Germany. Contact: support@biodegree.com.au. ABN 62 601 520 165.

Questions about this page? Contact support@biodegree.com.au.