ApprovalTrail

Medical device licence · 89131 · Class 3

DG GEL SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed June 27, 2012. It is in Health Canada’s list of active licences.
Licence number
89131
Licence holder
Diagnostic Grifols S.A.Parets Del Valles, 08, Spain
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
June 27, 2012
Devices covered
30

Devices on this licence

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

  • DG GEL AB (X4)
  • DG GEL ABO/RH (2D) (RT)
  • DG GEL ANTI-D
  • DG GEL NEUTRAL
  • DG GEL SYSTEM - DG GEL ABO-CDE
  • DG GEL SYSTEM - DG GEL ABO/RH (2D)
  • DG GEL SYSTEM - DG GEL ANTI-IGG
  • DG GEL SYSTEM - DG GEL CONFIRM P
  • DG GEL SYSTEM - DG GEL COOMBS
  • DG GEL SYSTEM - DG GEL DC SCAN
  • DG GEL SYSTEM - DG GEL NEWBORN
  • DG GEL SYSTEM - DG GEL SOL
  • DG GEL SYSTEM - DG GL RH PHENO+KELL
  • DG GEL SYSTEM - DG READER (MAIN UNIT)
  • DG GEL SYSTEM - DG SPIN (CENTRIFUGE)
  • DG GEL SYSTEM - DG THERM (INCUBATOR)
  • IDENTISERA DIANA
  • IDENTISERA DIANA EXTEND
  • IDENTISERA DIANA EXTEND P
  • IDENTISERA DIANA P
  • SERASCAN DIANA 2
  • SERASCAN DIANA 2P
  • SERASCAN DIANA 3
  • SERASCAN DIANA 3P
  • SERASCAN DIANA 4
  • SERASCAN DIANA 4P
  • SERASCAN DIANA DIA
  • SERIGRUP DIANA 4
  • SERIGRUP DIANA A1/B
  • SERIGRUP DIANA A2

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