EU Declaration of Conformity (MDD)
PDF · 0.2 MB · January 2025
Manufacturer's declaration of conformity in accordance with the Medical Device Directive (MDD) for Otinova® ear spray.
Documents & Compliance
Declarations of Conformity.
All regulatory documents for the medical devices distributed by BKmed — transparent, up to date and available as PDF at any time.
Otinova®
Ear spray without antibioticsManufacturer's Declaration
PDF · 1.5 MB · Current version
Supplementary manufacturer's declaration on composition, intended use and safety of Otinova®.
Further product documents are added on an ongoing basis. For additional regulatory files or batch-specific certificates, please get in touch with us.