CE marking
All Bio RIGENERA® O3 devices are CE-marked and authorised as medical devices for topical use.
E-E-A-T
Certifications
The credibility of Bio RIGENERA® rests on verifiable certifications and independent clinical attestations.
® ProRigenera® patents (tissue and bone regeneration) · Patent No. 102018000……
CE CE medical devices (Class IIa/IIb)
MS Notified to the Italian Ministry of Health
CH Tested by Istituto Antropos S.A., Lugano
IT All products Made in Italy
KFT Manufacturer Biostamina KFT
The class (IIa/IIb) refers only to the medical devices: Dental IIa; Cicatren and Dermal IIb. Pet: CE-marked professional veterinary phytotherapeutic product. Anti-age: cosmetic products.
Class IIa / IIb
Dental is class IIa; Cicatren and Dermal are class IIb. The class reflects the risk level and conformity route of the device.
Notified to the Ministry of Health
Devices notified to the Italian Ministry of Health. CND M040499 - dressings for wounds, sores and ulcers and the oral cavity.
Regeneration patents (2017)
The ozonated essential-oil technology is covered by filed patents.
Medical device vs cosmetic
The Bio RIGENERA® O3 range (Dental, Cicatren, Dermal) consists of CE medical devices for topical use. Bio RIGENERA® Pet is a professional veterinary phytotherapeutic product with CE marking. The Anti-Age dermocosmetic is instead a 100% natural serum of only 20 essential oils from medicinal plants with Gardenia stem cells: it nourishes, protects and improves the appearance of the skin, stimulating fibroblasts towards the natural production of collagen to fill wrinkles.