Kardium
心臓マッピングおよびアブレーション技術のメーカー。
Kardium は、心房細動治療用のグローブ マッピングおよびアブレーション システムを開発および製造しています。バーナビーの医療技術会社は、規制された医療機器チャネルを通じて電気生理学の研究室や病院の顧客にサービスを提供しています。
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer
- Location
- Burnaby, Canada
- Founded
- 2007
- Website
- kardium.com
- Categories
- 医療およびヘルスケア用品, 家電
- Markets
- カナダ, アメリカ合衆国, ドイツ
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
- domain-registered (green), checked 2026-08-08 Domain registry record
- sanctions-clear (green), checked 2026-08-08 - screened by name only: no legal entity is established for this record, so this is not a clearance OpenSanctions
- corporate-mail-on-domain (green), checked 2026-08-08 Mail server of the company domain
- debarment-clear (green), checked 2026-08-08 - screened by name only: no legal entity is established for this record, so this is not a clearance OpenSanctions
- fda-registered (green), checked 2026-08-08 FDA
Claimed certifications, not confirmed by us
- ISO 13485, Medical Devices Quality IAF CertSearch
- CE Marking EU NANDO (notified bodies)
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)