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Approvals and Awards

Medicap ® produces Biocompatible Artificial Hair and Implant Instruments, classified as Medical Devices and used as Remedy for Female and Male Baldness (alopecia) at any age and stage.

Thanks to the quality of medical devices developed and to the Safety of Biofibre Hair Implant as recognized hair restoration technique, Medicap received the following certifications:

  • CE 0373 certification mark based on 93/42/CEE directive;
  • UNI EN ISO 13485 certification for its Quality Assurance System used in the Production of Biofibre ® hair, Medicap High Density ® hair, Implant Instruments;
  • is included on Australian TGA (Therapeutic Goods Administration) list for its Medical Devices for hair Implant;
  • Medicap achieved registration of its Medical Devices (biocompatible Artificial Hair and implant Instruments) among Ministries of Health of all the countries where Biofibre Hair Implant is performed.

A scientific work carried out with the dermatologic surgery procedure Biofibre Hair Implant was awarded with the First Prize by the Scientific Committee of the International Society of Hair Restoration Surgery (ISHRS) as a token of the remedies effectiveness for alopecia (baldness) cases not treatable with other techniques. (ISHRS 10th Annual Meeting, Chicago, United States, October 9-13, 2002).

The scientific prime review Journal of Dermatologic Surgery published the paper ” Artificial Hair Fiber Restoration in the Treatment of Scalp Scars ” Dermatologic Surgery 2007 January; 33(1):35-44 that confirms the reliability of Biofibre Hair Implant as a solutions for female and male baldness (alopecia).

If you are interested in Medicap products or in Biofibre Hair Implant please contact us