nearly four years of testing against bacteria, fungi, and viruses passes every test.
-- Amatorus announced Thursday, after nearly four years of development and a battery of European efficacy tests. Specifically, the product met BS EN standards for killing off bacteria, fungi, and viruses—a baseline requirement for any company trying to sell infection-prevention tools to the healthcare market.
Amatorus has already had their lipstick which kills herpes approved by the MHRA and is now a Class 1 Medical Device. The Amatorus Lip Shield was invented to stop infection transmission between adults and babies which according to the WHO is 50% of under 5 year old.
While Class I is the MHRA’s designation for low-risk devices, the registration is a necessary gatekeeper for any manufacturer looking to move product through UK clinical channels. For Amatorus, it’s a shift from the lab to the market.
"This was about discipline," a company spokesperson said, noting that the registration validates the product's safety . "The goal was meeting those BS EN standards while making sure the formulation actually held up under medical device requirements. It’s been a long process, but now we can move to production."
The testing wasn't just a formality. The product had to prove its "triple action" claim against a range of pathogens. According to the company, the formula manages to hit these efficacy marks without relying on added chemical agents—a detail they’re leaning on to differentiate themselves in a crowded field. “We consider our product so far advanced that it is the Apple to Blackberry of wound care treatments,” added the spokesperson.
Wound care remains a massive, and expensive, headache for hospitals. In the U.S. alone, complications from infected wounds drain tens of billions of dollars from the healthcare system every year. By securing the MHRA nod, Amatorus is betting that its focus on antimicrobial resistance will resonate with providers looking to cut those costs and risks.
With the paperwork filed and the registration active, the company says it’s now moving into the distribution phase, looking for partners across the UK and in the near future, other regions with similar regulatory setups.
About Amatorus
Amatorus is a medical device firm centered on infection prevention. The company develops validated technologies aimed at mitigating viral, bacterial, and fungal risks within professional healthcare environments.
Amatorus said it is already applying for its FDA 510K and once approved, the company is set to begin distribution to hospitals and clinics that have already made pre-orders in the USA.
Contact Info:
Name: david stickland
Email: Send Email
Organization: AMATORUS WOUND GUARD
Website: http://amatorus.com/
Release ID: 89188860
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