ResolutionMD Inc.
Active in EUDAMEDCanadafrom SRN EUDAMED FDA SRN CA-MF-000031810 FEI 3006123366
ResolutionMD Inc. is a medical device manufacturer based in Canada, with 9 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (EU Class IIa; FDA Class II) as of 13 Nov 2026.
- Devices
- 9
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA GUDID 8
- EUDAMED 6
- FDA 510(k) 1
- Device classes
- EU Class IIa 6
- FDA Class II 3
- Top EMDN categories
- Sites and related companies
- CEpartner4U authorised representative
- Identifiers
- EUDAMED SRN CA-MF-000031810
- FDA FEI 3006123366
- DUNS 243325225
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA FEI
- Authorised rep.
- CEpartner4UNL
What ResolutionMD Inc. makes
ResolutionMD Inc. manufactures medical imaging software, including a platform for remote stroke assessment called StrokeViewer Image Viewer, a mobility analysis tool named Synapse Mobility, and a diagnostic system called ResolutionMD for neurological evaluations.
The company’s portfolio is classified under EU Medical Device Regulation as Class IIa devices and is registered in the EU’s eudamed database. ResolutionMD Inc. is based in Canada.
Catalogue
ResolutionMD Ref RESMD-D
Regimes: CE MDR Registry: EUDAMEDGUDIDNicolab Image Viewer Ref NLIV-D
Regimes: CE MDR Registry: EUDAMEDGUDIDSynapse Mobility Ref FFSM-D
Regimes: CE MDR Registry: EUDAMEDGUDIDResolutionMD Ref K260500
Regimes: 510(k) Registry: 510(k)- Registry: GUDID
- Registry: GUDID
ResolutionMD Ref RESMD-C
Regimes: CE MDR Registry: EUDAMEDGUDIDSynapse Mobility Ref FFSM-C
Regimes: CE MDR Registry: EUDAMEDGUDIDStrokeViewer Image Viewer Ref NLSV-C
Regimes: CE MDR Registry: EUDAMEDGUDID
Company details
- EUDAMED SRN
- CA-MF-000031810
- FDA FEI number
- 3006123366
- DUNS number
- 243325225
- EUDAMED status
- Active
- EUDAMED registered name
- ResolutionMD, Inc.
- EUDAMED abbreviated name
- ResMD
- Registered address
- 1212, 31 Avenue NE, T2E 7S8, Calgary, Canada
- Website
- www.resolutionmd.com
- Phone
- +15874304591
- PRRC contact
- Sharon Cholowsky
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 14 Dec 2028
BSI Group The Netherlands B.V. 2797 1 certificate
- MDR 819103 Active
Quality management system EU MDR
- Issued
- 9 Jan 2026
- Expires
- 14 Dec 2028
- Reason
- Ar srn change
Frequently asked questions
How many devices does ResolutionMD Inc. have in the registry?
The registry currently lists 9 devices for ResolutionMD Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list ResolutionMD Inc.'s devices?
Among its 9 most recently registered devices, ResolutionMD Inc. has devices listed in EUDAMED (6 devices), FDA 510(k) (1 device) and FDA GUDID (8 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do ResolutionMD Inc.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for ResolutionMD Inc.'s devices are Class IIa and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for ResolutionMD Inc.?
EUDAMED lists 1 certificate for ResolutionMD Inc. (quality management system) under MDR. The most recent was issued on 9 Jan 2026.
What are the newest devices from ResolutionMD Inc. in the registry?
The most recently registered devices listed for ResolutionMD Inc. include ResolutionMD, Nicolab Image Viewer, Synapse Mobility and ResolutionMD® Mobile RMD-MOB-I.