Medical device licence · 76040 · Class 2
SPECTRALIS
Yes: licensed in Canada
Licence status Issued (active); first licensed January 15, 2008. It is in Health Canada’s list of active licences.
- Licence number
- 76040
- Licence holder
- Heidelberg Engineering GmbhHeidelberg, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- January 15, 2008
- Devices covered
- 16
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- SPECTRALIS (HRA)
- SPECTRALIS (HRA+OCT)
- SPECTRALIS (OCT)
- SPECTRALIS HRA+OCT, FA
- SPECTRALIS HRA+OCT, FA,MC
- SPECTRALIS HRA+OCT, MC
- SPECTRALIS HRA, FA
- SPECTRALIS HRA, FA,MC
- SPECTRALIS HRA, MC
- SPECTRALIS OCT BLUE PEAK
- SPECTRALIS OCT BLUE PEAK, MC
- SPECTRALIS OCT MC
- SPECTRALIS OCT PLUS
- SPECTRALIS OCT PLUS BLUE PEAK
- SPECTRALIS OCT PLUS, BLUE PEAK, MC
- SPECTRALIS OCT PLUS, MC
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 “spectralis”. A notice may cover another product or only some lots: read it to see what it covers.
- SPECTRALIS® with Flex ModuleAugust 19, 2026 · Ophthalmology · Performance · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.