ApprovalTrail

Medical device licence · 78986 · Class 3

US-4000 ECHOSCAN

Yes: licensed in Canada

Licence status Issued (active); first licensed February 6, 2009. It is in Health Canada’s list of active licences.
Licence number
78986
Licence holder
Nidek Co., Ltd.Gamagori, 23, Japan
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
February 6, 2009
Devices covered
3

Devices on this licence

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

  • US-4000 ECHOSCAN - MAIN BODY
  • US-4000 ECHOSCAN - TEST PIECE (FOR PACHYMETRY MEASUREMENT)
  • US-4000 ECHOSCAN - US-9 PACHYMETRY PROBE

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