ApprovalTrail

Medical device licence · 96742 · Class 2

CARDIOVIT FT-1

Yes: licensed in Canada

Licence status Issued (active); first licensed March 24, 2016. It is in Health Canada’s list of active licences.
Licence number
96742
Licence holder
Schiller AgBaar, ZG, Switzerland
Risk class
Class II (low to moderate risk)
Licence type
System
First licensed
March 24, 2016
Devices covered
17

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

  • ABRASIVE PADS CARDIO-PREPS
  • ADAPTER CABLE FOR SUCTION DEVICE COMPATIBLE WITH FT-1, MS-12 USB
  • ADULT CLAMP EXTREMITY ELECTRODE
  • BLUE SENSOR DISPOSABLE ECG ELECTRODE
  • CARDIOVIT FT-1
  • ETM SOFTWARE FT-1
  • GROUNDING CABLE
  • MAINS CABLE SCHUKO EUROPE
  • MEDICAL GRADE AC/DC POWER ADAPTER
  • PATIENT CABLE
  • SCHILLER BIOTABS AG/AGC, DISPOSABLE ELECTRODES
  • SCHILLER CULPRIT CORONARY ARTERY ALGORITHM SOFTWARE
  • SET OF ADULT ECG ELECTRODES
  • SET OF CHILDREN ECG ELECTRODES
  • SET OF STANDARD ACCESSORIES FT-1
  • SNAP-CLIP ADAPTER FOR BANANA-PLUG CABLES
  • SUCTION ELECTRODE

Recalls and safety alerts that mention it

Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “cardiovit”. A notice may cover another product or only some lots: read it to see what it covers.

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.