1
/
of
2
Endura
Gelhorn
Gelhorn
No reviews
Regular price
$0.00 NZD
Regular price
Sale price
$0.00 NZD
Unit price
/
per
Couldn't load pickup availability
Gelhorn pessaries are non-surgical tools for treating third or fourth-degree pelvic organ prolapse.
All prices are exclusive of GST. Our ring pessary is made from FDA-registered long-term medical-grade silicone with no additives. All orders are subject to our Terms of Trade.
Frequently Asked Questions
What is different about Endura?
Unlike other pessaries in the market, Endura does not contain any additives, such as colourant, to mitigate any risk of vaginal irritation.
Additionally, we offer Endura in two hardnesses, Comfort and FirmAid for our Ring pessary, to ensure patients find the perfect fit for their comfort and support needs.
Who makes Endura?
The Endura pessary range is manufactured by ESP Medical in Hamilton, New Zealand. ESP Medical is an ISO 13485:2016 certified medical device manufacturer with over 30 years of experience in silicone injection moulding for pharmaceutical industry. ESP Medical operates a clean room facility for medical device and pharmaceutical manufacturing.
What testing does Endura go through?
The Endura has undergone mechanical testing influenced by the Queen's University, Belfast Mechanical Testing for Vaginal Rings paper.
Each Endura production batch goes through a process of microbial testing with limited specified as per the ISO 11737:2018 to ensure we are not introducing any bacteria through the manufacturing process.
Endura is made using only FDA registered long-term (>30 days) medical-grade silicone.
Is Endura FDA Registered?
The Endura product is not currently registered with the FDA. However, we are an ISO 13485 approved medical device manufacturer and have registered the Endura through the MEDSAFE WAND system which enables us to sell in NZ.
What risk classification of medical devices does Endura fall under?
Class IIb - our product is intended for use for more than 30 days inside a bodily orifice.
Subscribe to our emails
Be the first to know about our new pessary range. Watch this space!
Access Denied
IMPORTANT! If you’re a store owner, please make sure you have Customer accounts enabled in your Store Admin, as you have customer based locks set up with EasyLockdown app. Enable Customer Accounts