Kardium
Fabricante de tecnología de ablación y mapeo cardíaco.
Kardium desarrolla y fabrica el sistema de ablación y mapeo de globo para el tratamiento de la fibrilación auricular. La empresa Burnaby medtech presta servicios a laboratorios de electrofisiología y a clientes de hospitales a través de canales regulados de dispositivos médicos.
- Type
- brand seeking distribution
- Location
- Burnaby, Canada
- Founded
- 2007
- Website
- kardium.com
- Categories
- Suministros médicos y sanitarios, Electrónica de consumo
- Markets
- Canadá, Estados Unidos, Alemania
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)