Planmeca
歯科用ユニット、イメージング システム、CAD/CAM システム、歯科用器具。
Planmeca は、ヘルシンキの事業所で歯科ユニット、イメージング システム、CAD/CAM システム、歯科用器具を製造しています。同社は、病院のバイヤー、臨床販売代理店、ヘルスケア システム、または上場主要市場全体の輸出顧客に製品を供給しています。
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer
- Location
- Helsinki, Finland
- Founded
- 1971
- Website
- planmeca.com
- Categories
- 医療およびヘルスケア用品, 産業用品, 歯科用品および歯科用機器
- Markets
- フィンランド, ドイツ, アメリカ合衆国, 日本
What is established and what is not
No facet of this company has been investigated yet. The facts below are collected records, not an assessment: nothing here confirms manufacturing, ownership or trading status beyond what each record literally says.
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)
- registry-id-verified (green), checked 2026-09-10 GLEIF Global LEI record
Claimed certifications, not confirmed by us
- 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)