Medical device licence · 86641 · Class 3
CARDIOHELP-I
Yes: licensed in Canada
Licence status Issued (active); first licensed July 15, 2011. It is in Health Canada’s list of active licences.
- Licence number
- 86641
- Licence holder
- Maquet Cardiopulmonary GmbhRastatt, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- July 15, 2011
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CARDIOHELP BASE UNIT
- CARDIOHELP COUNTRY KIT ENGLISH/FRENCH CANADA
- CARDIOHELP EMERGENCY DRIVE
- CARDIOHELP-I
- VENOUS PROBE CARDIOHELP
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “cardiohelp-i”. A notice may cover another product or only some lots: read it to see what it covers.
- Cardiohelp-IApril 8, 2024 · Gastroenterology and urology · Performance · Type II
- Cardiohelp-iDecember 4, 2023 · Gastroenterology and urology · Performance · Type II
- Cardiohelp-IOctober 13, 2023 · Gastroenterology and urology · Performance · Type I
- Cardiohelp-ISeptember 11, 2023 · Gastroenterology and urology · Performance · Type II
- Cardiohelp-IFebruary 28, 2022 · Gastroenterology and urology · Manufacturing defect · Type II
- Cardiohelp-I (2013-09-04)September 27, 2013 · Medical devices · Medical devices · Type III
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.