Multigate Medical Products
Australian single-use surgical consumables for Australasian hospitals.
Multigate Medical Products is an Australian manufacturer and distributor of single-use medical and surgical consumables, producing procedure packs, drapes, gowns, swabs, wound-care items, and anaesthesia accessories at TGA-licensed facilities in New South Wales. The company's surgical drape and gown range is manufactured to EN 13795 surgical textile standards and is supplied to public and private hospitals across Australia and New Zealand. Multigate also distributes specialist products sourced from international partners in Europe and the United States through its Australasian hospital supply network.
- Type
- Manufacturer
- Location
- Villawood, Australia
- Founded
- 1988
- Website
- multigate.com.au
- Categories
- Medical & Healthcare Supplies
- Markets
- Australia, New Zealand, Singapore, Malaysia
Verified facts
- certificate-page-on-site (amber), checked 2026-08-11 Company's own certification page
Claimed certifications
- ISO 13485, Medical Devices Quality IAF CertSearch
- ISO 9001, Quality Management IAF CertSearch
- CE Marking EU NANDO (notified bodies)
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)