Pure Global AI
EUDAMED registration B037FFSMC0Yes

ResolutionMD

ResolutionMD, Inc.Class IIaEU EUDAMEDTrade name: Synapse Mobility
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class IIa
CND nomenclatures code
Z11069092
Trade name
Synapse Mobility
Implantable
No
Reusable
No
Measuring function
Yes
Registration information
Primary DI
B037FFSMC0
Basic UDI
++B037RESMDCXM
Active status
Yes
Manufacturer
Manufacturer name
ResolutionMD, Inc.
Country
Canada
Country type
NON_EU
Address
1212 31 Avenue NE Calgary
Email
regulatory@resolutionmd.com
Authorized representative
Name
CEpartner4U
SRN
NL-AR-000000111
Country
Netherlands
Address
13 Esdoornlaan Maarn
Email
office@cepartner4u.com
Telephone
+31343442524
Regulatory information
Competent authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed on the market
France
Market available
Austria:2025-01-01~None, Belgium:2024-01-01~None, France:2024-01-01~None, Germany:2024-01-01~None, Italy:2024-01-01~None, Netherlands:2024-01-01~None, Poland:2024-01-01~None, Portugal:2024-01-01~None, Spain:2024-01-01~None, Sweden:2025-01-01~None, Türkiye:2024-01-01~None
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE

About this record

Access comprehensive regulatory information for ResolutionMD in the European Union medical device market through Pure Global AI's free database. This Class IIa device is registered with EU EUDAMED under Primary DI B037FFSMC0 and manufactured by ResolutionMD, Inc. in Canada.

This page provides complete registration details including trade name (Synapse Mobility), manufacturer information, authorized representative details, competent authority (Ministerie van Volksgezondheid, Welzijn en Sport), and regulatory compliance data from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry, helping global MedTech companies navigate EU MDR regulations efficiently.