Kardium
Fabricant de technologies de cartographie cardiaque et d’ablation.
Kardium développe et fabrique le système de cartographie et d'ablation du globe pour le traitement de la fibrillation auriculaire. La société de technologie médicale de Burnaby dessert les laboratoires d'électrophysiologie et les hôpitaux par le biais de canaux réglementés en matière de dispositifs médicaux.
- Type
- brand seeking distribution
- Location
- Burnaby, Canada
- Founded
- 2007
- Website
- kardium.com
- Categories
- Fournitures médicales et de santé, Électronique grand public
- Markets
- Canada, États-Unis, Allemagne
Verified facts
- domain-registered (green), checked 2026-08-08 Domain registry record
- sanctions-clear (green), checked 2026-08-08 OpenSanctions
- corporate-mail-on-domain (green), checked 2026-08-08 Mail server of the company domain
- debarment-clear (green), checked 2026-08-08 OpenSanctions
- fda-registered (green), checked 2026-08-08 FDA
Claimed certifications
- ISO 13485, Medical Devices Quality IAF CertSearch
- CE Marking EU NANDO (notified bodies)
- FDA Registered FDA Establishment Registration
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)