Medical device licence · 85994 · Class 2
IV ADMINISTRATION SETS
Yes: licensed in Canada
Licence status Issued (active); first licensed May 2, 2011. It is in Health Canada’s list of active licences.
- Licence number
- 85994
- Licence holder
- Eitan Medical Ltd.Netanya, Israel
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- May 2, 2011
- Devices covered
- 15
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BLOOD SET
- INFUSION SET WITH NON-VENTED SPIKE
- INFUSION SET WITH SPIN MALE LUER LOCK
- INFUSION SET WITH VENTED/NON VENTED DRIP CHAMBER
- MICROBORE
- MICROBORE ADMINISTRATION SET
- MICROBORE EPIDURAL ADMINISTRATION SET
- MICROBORE INFUSION SET WITH 2 SPIN MALE LUER LOCK
- MICROBORE INFUSION SET WITH FEMALE LUER LOCK, FX DMINISTRATION CASSETTE, SLIDE CLAMP, NEEDLESS Y-SITE AND SPIN MALE LUER LOCK
- MICROBORE INFUSION SET WITH NON-VENTED SPIKE
- MICROBORE INFUSION SET WITH VENTED/NON VENTED SPIKE
- NON PVC INFUSION SET WITH VENTED/NON VENTED DRIP CHAMPER
- PRIMARY INFUSION SET WITH VENTED/NON VENTED DRIP CHAMBER
- SECONDARY INFUSION SET WITH VENTED/NON VENTED DRIP CHAMBER
- UV RESISTANT INFUSION SET WITH VENTED/NON VENTED DRIP CHAMBER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.