Medical device licence · 63574 · Class 2
HSCRIBE HOLTER ANALYSIS SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed January 21, 2004. It is in Health Canada’s list of active licences.
- Licence number
- 63574
- Licence holder
- Welch Allyn, Inc.San Diego, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- January 21, 2004
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- H-SCRIBE
- H-SCRIBE ACCESSORY KITS
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 “hscribe”. A notice may cover another product or only some lots: read it to see what it covers.
- HScribe, RScribe, XScribe, Q-Stress, and Welch Allyn Diagnostic Cardiology Suite; Connex CardioOctober 30, 2024 · Cardiovascular · Performance · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.