Facilities, manufacturing and intellectual property
Biocoral France occupies two sites. The manufacturer facility operated previously until 2005 with the name of Inoteb is located in west of France "Saint-Gonnery" in France which was founded in 1985 by a group of fonder represented by Mr. Jean Darondel (Inoteb's former President Director General, and former Chairman of Board of directors and one of the Biocoral, Inc. actual member of the Board of Directors), and the executive administrative center at La Garenne Colombes (Paris Area). The manufacturer facility, complies with ISO 13485 (2012).
BIOCORAL® CONFORMITIES WITH THE EUROPEAN AND INTERNATIONAL NORMS.
Biocoral® although marketed since the end of the years 80, was the first bone substitute registered in France with TIPS (Tarifs Interministériels des Prestation Sanitaires). Nevertheless within the framework of its registration, Biocoral® has been received approving opinion of Microbiological Committee of Health on July 05, 1995 referenced under the number 9600201B01.
Biocoral® received the certifications for marketing in the European countries market "EC lable" on December 30, 1996. Since, these certifications have been renewed several times and they are into force currently.
Biocoral France manufactures bone graft substitute composed of "Carbonate Calcium" (more than 98%) derived from the mineral part of natural coral which is used by surgeons and practitioners for more than 30 years because of its biocompatibility, resorbability, osseous conduction and safety.
Management Quality ISO 13485 (2012)
|EC CertificateAnnexe III||EC Certification Annexe V|
These products are commercialized under the trademark Biocoral®, a natural biomaterial bone graft substitute wholly mineral for filling, which is perfectly biocompatible and can be used in different fields of bone surgery: orthopaedics, neurosurgery, maxillofacial surgery and oral surgery.