Kardium
صانع خرائط القلب وتكنولوجيا الاجتثاث.
تقوم شركة Kardium بتطوير وتصنيع نظام رسم الخرائط والاستئصال العالمي لعلاج الرجفان الأذيني. تخدم شركة Burnaby medtech مختبرات الفيزيولوجيا الكهربية وعملاء المستشفيات من خلال قنوات الأجهزة الطبية المنظمة.
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer
- Location
- Burnaby, Canada
- Founded
- 2007
- Website
- kardium.com
- Categories
- اللوازم الطبية والرعاية الصحية, الالكترونيات الاستهلاكية
- Markets
- كندا, الولايات المتحدة, ألمانيا
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)