Osstem Implant Denmark
Sistemas de implantes dentales y equipos quirúrgicos para Escandinavia.
Osstem Implant Denmark es el brazo de distribución nórdico de Osstem Implant (Corea del Sur), que suministra implantes dentales, sistemas de cirugía guiada y soluciones de odontología digital a clínicas dentales y proveedores de laboratorio escandinavos.
- Type
- brand seeking distribution
- Location
- Aarhus, Denmark
- Founded
- 2000
- Website
- osstem.dk
- Categories
- Suministros médicos y sanitarios, Suministros y equipos dentales
- Markets
- Dinamarca, Alemania, Suecia, Noruega
Claimed certifications
- CE Marking EU NANDO (notified bodies)
- ISO 9001, Quality Management IAF CertSearch
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)