Planmeca
Unidades dentales, sistemas de imagen, sistemas CAD/CAM e instrumentos odontológicos.
Planmeca fabrica unidades dentales, sistemas de imágenes, sistemas CAD/CAM e instrumentos dentales desde sus operaciones en Helsinki. La empresa abastece a compradores de hospitales, distribuidores clínicos, sistemas de salud o clientes de exportación en sus mercados primarios listados.
- Type
- brand seeking distribution
- Location
- Helsinki, Finland
- Founded
- 1971
- Website
- planmeca.com
- Categories
- Suministros médicos y sanitarios, Suministros industriales, Suministros y equipos dentales
- Markets
- Finlandia, Alemania, Estados Unidos, Japón
Verified facts
- certificate-page-on-site (amber), checked 2026-08-11 Company's own certification page
- standards-mark-certified (green), checked 2026-08-16 EAEU unified register of certificates and declarations
- registry-activity (green), checked 2026-07-09 Finnish Patent and Registration Office (PRH)
- domain-registered (green), checked 2026-08-02 Domain registry record
- lei-active (green), checked 2026-08-23 GLEIF global LEI register (golden copy)
- registry-active-global (green), checked 2026-07-09 Finnish Patent and Registration Office (PRH)
Claimed certifications
- ISO 13485, Medical Devices Quality IAF CertSearch
- CE Marking EU NANDO (notified bodies)
- EAC mark (EAEU conformity) EAEU unified register of certificates and declarations
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)