Kardium
Fabricante de tecnologia de mapeamento e ablação cardíaca.
A Kardium desenvolve e fabrica o Sistema de Mapeamento e Ablação do Globo para tratamento de fibrilação atrial. A empresa medtech Burnaby atende laboratórios de eletrofisiologia e clientes hospitalares por meio de canais regulamentados de dispositivos médicos.
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer
- Location
- Burnaby, Canada
- Founded
- 2007
- Website
- kardium.com
- Categories
- Suprimentos médicos e de saúde, Eletrônicos de consumo
- Markets
- Canadá, Estados Unidos, Alemanha
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)