Medical device licence · 89847 · Class 2
INTRICON DATRIX SIRONA
No longer licensed: suspended: invalid quality-system certificate
Licence status Suspended: invalid quality-system certificate; first licensed October 10, 2012; ended July 29, 2019. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 89847
- Licence holder
- Datrix, LlcEscondido, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- October 10, 2012
- Ended
- July 29, 2019
- Devices covered
- 22
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- SIRONA 2 WIRE 1-CHANNEL EVENT CABLE
- SIRONA 3 WIRE 1-CHANNEL EVENT CABLE
- SIRONA 3 WIRE 2-CHANNEL EVENT CABLE
- SIRONA 5 WIRE 2-CHANNEL HOLTER CABLE
- SIRONA 5 WIRE 3-CHANNEL HOLTER CABLE
- SIRONA 5 WIRE 5-CHANNEL EVENT CABLE
- SIRONA 7 WIRE 3-CHANNEL HOLTER CABLE
- SIRONA 7 WIRE PATIENT CABLE - 3 CHANNEL HOLTER
- SIRONA CHARGING CABLE
- SIRONA HOLTER / EVENT RECORDER AMI
- SIRONA HOLTER / EVENT RECORDER CARDIOLABS
- SIRONA HOLTER / EVENT RECORDER CARDIOSTAFF
- SIRONA HOLTER / EVENT RECORDER DATRIX
- SIRONA HOLTER / EVENT RECORDER HEARTCOR
- SIRONA LINKSTREAM
- SIRONA PATCH
- SIRONA PATCH ADAPTER ACCESSORY
- SIRONA PATIENT WORN MODULE
- SIRONA POST EVENT ADAPTER ACCESSORY
- SIRONA SMART DOCK
- SIRONA USB CABLE
- SIRONA WALL CHARGER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.