Planmeca
Dental units, imaging systems, CAD/CAM systems and dental instruments.
Planmeca manufactures dental units, imaging systems, CAD/CAM systems and dental instruments from its Helsinki operations. The company supplies hospital buyers, clinical distributors, healthcare systems or export customers across its listed primary markets.
- Type
- Manufacturer
- Location
- Helsinki, Finland
- Founded
- 1971
- Website
- planmeca.com
- Categories
- Medical & Healthcare Supplies, Industrial Supplies, Dental Supplies & Equipment
- Markets
- Finland, Germany, United States, Japan
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
- registered-manufacturer (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)