Medical device licence · 1346 · Class 2
KEYPOINT SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed February 16, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 1346
- Licence holder
- Natus Manufacturing LimitedGort, GW, Ireland
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- February 16, 1999
- Devices covered
- 36
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- KEYPOINT SYSTEM - ADAPTOR
- KEYPOINT SYSTEM - AMPLIFIER
- KEYPOINT SYSTEM - ANALOG OUTPUT BOARD
- KEYPOINT SYSTEM - BONE CONDUCTOR
- KEYPOINT SYSTEM - CC STIM HANDGRIP SET
- KEYPOINT SYSTEM - ELECTRODE TIP
- KEYPOINT SYSTEM - EP AMPLIFIER (HEADBOX)
- KEYPOINT SYSTEM - FOOT SWITCH
- KEYPOINT SYSTEM - GOGGLES
- KEYPOINT SYSTEM - HANDGRIPS
- KEYPOINT SYSTEM - HEADSET/EARPHONES
- KEYPOINT SYSTEM - ISOLATING TRANSFORMER
- KEYPOINT SYSTEM - KEYPOINT 4
- KEYPOINT SYSTEM - KEYPOINT CABLES
- KEYPOINT SYSTEM - KEYPOINT PORTABLE 2
- KEYPOINT SYSTEM - KEYPOINT PORTABLE 4
- KEYPOINT SYSTEM - KEYPOINT PORTABLE, MODEL FOCUS
- KEYPOINT SYSTEM - KEYPOINT PORTABLE, MODEL FOCUS, AMPLIFIER BOX
- KEYPOINT SYSTEM - KEYPOINT PORTABLE, MODEL FOCUS, SOFTWARE
- KEYPOINT SYSTEM - KEYPOINT PORTABLE, MODEL FOCUSM CART
- KEYPOINT SYSTEM - KEYPOINT SOFTWARE
- KEYPOINT SYSTEM - KEYPOINT WORKSTATION, MODEL G4
- KEYPOINT SYSTEM - KEYPOINT WORKSTATION, MODEL G4, AMPLIFIER BOX
- KEYPOINT SYSTEM - KEYPOINT WORKSTATION, MODEL G4, CC STIM
- KEYPOINT SYSTEM - KEYPOINT WORKSTATION, MODEL G4, LAN KIT
- KEYPOINT SYSTEM - KEYPOINT WORKSTATION, MODEL G4, NET HASP LICENSE
- KEYPOINT SYSTEM - KEYPOINT WORKSTATION, MODEL G4, PRINTER COLOUR
- KEYPOINT SYSTEM - KEYPOINT WORKSTATION, MODEL G4, PRINTER S/W
- KEYPOINT SYSTEM - KEYPOINT.NET
- KEYPOINT SYSTEM - NEURO ACCESSORIES KIT
- KEYPOINT SYSTEM - SILICONE SOUND TUBES
- KEYPOINT SYSTEM - STIMULATOR
- KEYPOINT SYSTEM - TENDON HAMMER
- NATUS KEYPOINT
- NATUS KEYPOINT FOCUS
- NATUS KEYPOINT G4
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 “keypoint”. A notice may cover another product or only some lots: read it to see what it covers.
- Keypoint System - EP Amplifier (Headbox) (2015-11-01)February 1, 2016 · Medical devices · Health products · Type II
- Software Keypoint.Net Version 2.20June 17, 2013 · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.