ApprovalTrail

Medical device licence · 97068 · Class 2

HF-RESECTION ELECTRODE

Yes: licensed in Canada

Licence status Issued (active); first licensed June 10, 2016. It is in Health Canada’s list of active licences.
Licence number
97068
Licence holder
Olympus Winter & Ibe GmbhHamburg, 02, Germany
Risk class
Class II (low to moderate risk)
Licence type
Device Family
First licensed
June 10, 2016
Devices covered
1

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

  • HF-RESECTION ELECTRODE

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 “hf-resection”. A notice may cover another product or only some lots: read it to see what it covers.

  • Olympus HF-Resection ElectrodeJuly 13, 2023 · Gastroenterology and urology - General and plastic surgery - Ophthalmology · Labelling and packaging · Type II

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.