Regulatory information
Koretreat Market SAS is the certified importer of the BiViDerma family in Ecuador.
ARCSA sanitary registration
Registration number ARCSA-2023-3.3-0000041. The product is registered with the Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (ARCSA) under classification Class III medical device — cross-linked hyaluronic acid for soft-tissue augmentation.
Importer of record
Koretreat Market SAS · RUC [TODO: insert RUC] · Quito, Ecuador. Authorised representative: [TODO: name and position].
Manufacturer
[TODO: legal review] BiViDerma is manufactured in South Korea in ISO 13485-certified facilities. Insert manufacturer legal name and address; cite GMP / KFDA documentation references.
Product family
BiViDerma I (light, fine lines), BiViDerma III (medium, mid-face), BiViDerma V (high density, deep volume). Each variant includes 0.3% lidocaine hydrochloride. Refer to the Instructions for Use shipped with every unit.
Storage and traceability
Ambient storage 5–23 °C, away from direct sunlight; do not freeze. Every unit is shipped with batch number and expiry. Lot traceability documentation is available to certified practitioners on request.
Adverse event reporting
Suspected adverse events must be reported. See the Pharmacovigilance page for the reporting procedure and the 24/7 clinical hotline.
Documentation requests
Practitioners may request the full regulatory dossier (Certificate of Origin, ARCSA letter, Certificate of Free Sale, technical file) by emailing regulatorio@koretreat.com.
Regulatory affairs: regulatorio@koretreat.com · ARCSA hotline 24/7: +593 988 089 010.