Medical device licence · 11562 · Class 2
HYDRAGEL HYDRASYS SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed September 8, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 11562
- Licence holder
- SebiaEvry Cedex, France
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- September 8, 1999
- Devices covered
- 32
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- 5 VON WILLEBRAND MULTIMERS VISUALIZATION KIT
- DARATUMUMAB CONTROL
- DILUENT DTT (IF/IT)
- HYDRAGEL 11 VON WILLEBRAND MULTIMERS
- HYDRAGEL 5 VON WILLEBRAND MULTIMERS
- HYDRAGEL HYDRASYS - 15 LDLHDL CHOL DIRECT
- HYDRAGEL HYDRASYS - 18 A1AT ISOFOCUSING KIT
- HYDRAGEL HYDRASYS - 2 IF/BJ HR
- HYDRAGEL HYDRASYS - 2IF ACID VIOLET
- HYDRAGEL HYDRASYS - 2IF AMIDOBLACK
- HYDRAGEL HYDRASYS - 3 CSF ISOFOCUSING
- HYDRAGEL HYDRASYS - 6 CSF
- HYDRAGEL HYDRASYS - 7 HBA1C
- HYDRAGEL HYDRASYS - 7 ISO-PAL (ALKALINE PHOSPHATASE)
- HYDRAGEL HYDRASYS - 7 LIPO AND LP(A)
- HYDRAGEL HYDRASYS - 9 CSF ISOFOCUSING
- HYDRAGEL HYDRASYS - ANTI-TRANSFERRIN(E) ANTISERUM
- HYDRAGEL HYDRASYS - BENCE JONES PROTEIN
- HYDRAGEL HYDRASYS - HYDRAGEL 6 BETA2 TRANSFERRIN(E)
- HYDRAGEL HYDRASYS - IF PENTA
- HYDRAGEL HYDRASYS - INSTRUMENT - CLASS 2
- HYDRAGEL HYDRASYS - ISO CK
- HYDRAGEL HYDRASYS - ISO-LDH
- HYDRAGEL HYDRASYS - LIPOPROTEIN
- HYDRAGEL HYDRASYS - PROTEIN
- HYDRAGEL HYDRASYS - PROTEINURIA
- HYDRAGEL HYDRASYS- IT/IF CONTROL
- HYDRASHIFT 2/4 ACCESSORIES
- HYDRASHIFT 2/4 DARATUMUMAB
- HYDRASHIFT 2/4 ISATUXIMAB
- HYDRASYS 5 VON WILLEBRAND MULTIMERS ACCESSORIES
- ISATUXIMAB CONTROL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.