Scican Ltd
Active in EUDAMEDCanadafrom SRN EUDAMED FDA SRN CA-MF-000045917
Scican Ltd is a medical device manufacturer based in Canada, with 137 devices listed in FDA GUDID, FDA 510(k) and EUDAMED (FDA Class II and I; EU Class I) as of 13 Nov 2026.
- Devices
- 137
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA GUDID 124
- FDA 510(k) 11
- EUDAMED 5
- Device classes
- FDA Class II 123
- FDA Class I 9
- EU Class I 5
- Top EMDN categories
- Sites and related companies
- SciCan GmbH authorised representative
- Identifiers
- EUDAMED SRN CA-MF-000045917
- DUNS 204137145
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA establishment
- Authorised rep.
- SciCan GmbHDE
What Scican Ltd makes
Scican Ltd manufactures autoclaves for sterilizing medical instruments, including the STATCLAVE G4, Bravo G4, and Bravo Autoclave models (17, 17V, 21V). Their portfolio also includes handpiece maintenance units like the STATMATIC 31 and STATIS Dental Handpieces, as well as instrument reprocessing containers such as the SALUS. Additionally, they produce cleaning solutions for orthopedic implants (HIP ULTRA and HIP Cleaning Solution) and specialized handpiece systems like the Hydrim C61 LCS.
The company’s devices are classified under EU Class I and Class II regulations, with listings in the EUDAMED database and FDA’s 510(k) registry. Their products are designed for dental and orthopedic reprocessing, adhering to sterilization and hygiene standards. The company is based in Canada.
Catalogue
Search and filter all 137 devicesShowing 1-50 of 137
Company details
- EUDAMED SRN
- CA-MF-000045917
- DUNS number
- 204137145
- EUDAMED status
- Active
- EUDAMED registered name
- SciCan Ltd.
- Registered address
- 1440, Don Mills Road, M3B 3P9, Toronto, Canada
- Phone
- 18006677733
- PRRC contact
- Kelly Makimoto
FDA establishments
- Scican GmbH US
Frequently asked questions
How many devices does Scican Ltd have in the registry?
The registry currently lists 137 devices for Scican Ltd. Devices recorded under merged duplicate company entries are counted once.
Which registries list Scican Ltd's devices?
Among its 50 most recently registered devices, Scican Ltd has devices listed in FDA 510(k) (2 devices) and FDA GUDID (48 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Scican Ltd's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Scican Ltd's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Scican Ltd in the registry?
The most recently registered devices listed for Scican Ltd include STATIM 6000B Vacuum Autoclave, STATIM 2000 G4 CASSETTE, STATIM 5000 Cassette Autoclave 01-201103-R and BRAVO 21V Autoclave M7A320011-R.
Which FDA establishments are linked to Scican Ltd?
1 FDA establishment is linked to Scican Ltd in the registry; they are listed on the company page.