Medical device licence · 96323 · Class 3
LEEP PRECISION INTEGRATED SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed January 4, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 96323
- Licence holder
- Coopersurgical, Inc.Trumbull, CT, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- January 4, 2016
- Devices covered
- 14
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DUAL DISPERSIVE ELECTRODES WITH CONNECTOR
- FOOT PEDAL ADAPTER
- FOOT PEDAL-OPERATED CAUTERY PENCILS
- HAND SWITCH-OPERATED PUSH-BUTTON CAUTERY PENCILS
- INTEGRATION UNIT
- LEEP PRECISION CART
- LEEP PRECISION GENERATOR
- LEEP PRECISION INTEGRATED SYSTEM
- LEEP PRECISION SMOKE EVACUATOR
- REUSABLE ELECTROSURGICAL GROUNDING PAD CABLE
- SMOKE EVACUATOR PRE-FILTER
- SMOKE EVACUATOR REDUCER
- SMOKE EVACUATOR TUBING
- SMOKE EVACUATOR ULPA FILTER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.