Dermaroller^® Germany

In the last 1990's, Dermaroller® founder, Horst Liebl, after settling in France, started researching, engineering  and perfecting the micro-needling concept leading to the development of the Original Dermaroller ®. The initial intent was to develop an instrument that would safely, quickly, effectively and painlessly deliver transcutaneously active substances through the stratum corneum without side-effects.

In 2000, the University of Marburg in Germany confirmed Dermaroller’s® efficacy of transcutaneous delivery in two clinical studies. Subsequent clinical studies and trials confirmed that micro-needles induced a substantial amount of new collagen and elastin fibers (neo-collagenesis) as well as new capillaries (neo-angiogenesis) in human skin. That same year, Dermaroller ® was patented in Germany and trademarked in the Europe Union (EU) and then in the USA.

In 2004, Dermaroller® was certified as a medical device. Initial sales begun in the Far East being that needling was not a foreign concept. In less than nine months Dermaroller ® became popular throughout Asia.  News of the efficacy the Dermaroller devices quickly spread to Europe as did sales. It was then introduced to the USA where the Dermaroller ® became Registered with the FDA as a surgical instrument.

In 2007, the original production plant in France was outgrown. A new fabrication site in Wolfenbuettel, Germany was built. The company was re-structured and renamed Dermaroller Deutschland GmbH It was certified as a manufacturer for medical devices in compliance with ISO 13485*. All Dermarollers ® are deemed to be medical devices and are CE-marked by the Notifying Body Medcert GmbH in Hamburg, Germany, registration number 0485.

Dermaroller® devices have become accepted, acknowledged and well respected medical devices in the medical community. Scientific literature refers to Dermaroller® synonymously with Collagen Induction Therapy (CIT) and micro-needling. Dermaroller® ensures your practices’ and patients’ safety. We are the only micro-needling device to earn the world's most demanding certifications:

• Registered with the FDA as a Class I Medical Device and GMP (Good Manufacturing Practice) 
• Certified as a surgical micro-needling device
• CE (Conformité Européene) certified in the European Union**
• TGA (Therapeutic Goods Administration) approved as a Class II Medical Device in Australia

More Dermaroller® facts:
• The original inventor of the micro-needling concept
• Preferred device for use in international micro-needling and CIT studies
• The world’s most established micro-needling company (in business since 2000)
• Performed over 700,000 successful procedures worldwide
• Guaranteed quality
• Medical Dermaroller® models are guaranteed to be sterilely packaged on arrival

   *ISO 13485 - International Organization of Standards for the manufacturing of medical devices
** A certifying mark that a packaged product meets or exceeds EU health, safety and environmental requirements that ensure consumer and workplace safety.