Medical device licence · 5421 · Class 2
SUBCUTANEOUS INFUSION SETS
Yes: licensed in Canada
Licence status Issued (active); first licensed June 15, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 5421
- Licence holder
- Unomedical Inc.Lejre, Denmark
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group Family
- First licensed
- June 15, 1999
- Devices covered
- 34
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ACCU-CHEK TENDER INFUSION SET - ACCU-CHEK TENDER I
- ACCU-CHEK TENDER INFUSION SET - ACCU-CHEK TENDER II
- ACCU-CHEK TENDERLINK INFUSION SET
- AUTOSOFT 30
- AUTOSOFT 90
- COMFORT INFUSION SETS
- COMFORT SHORT INFUSION SETS
- CONTACT DETACH INFUSION SETS
- INSET 30 SUBCUTANEOUS INFUSION SETS
- INSET II INFUSION SETS
- MINIMED MIO 30
- MINIMED MIO ADVANCE
- MINIMED MIO ADVANCE, SC1
- MINIMED QUICK-SET
- MINIMED SILHOUETTE
- MINIMED SURE-T
- MIO INFUSION SETS
- NERIA DETACH
- NERIA GUARD 2-PACK
- NERIA GUARD CANNULA
- NERIA SOFT 90
- NERIA SOFT SUBCUTANEOUS INFUSION SET
- NERIA SUBCUTANEOUS INFUSION SETS
- PARADIGM QUICK-SET INFUSION SETS
- PARADIGM SILHOUETTE INFUSION SETS
- PARADIGM SURE-T INFUSION SET
- QUICK-SET INFUSION SETS
- SILHOUETTE INFUSION SETS
- SILHOUETTE PARADIGM 2-PACK
- THALASET G27 INFUSION SETS
- THALASET G29 INFUSION SETS
- TRUSTEEL
- VARISOFT
- YPSOPUMP INSET
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.