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Synapse Mobility

by ResolutionMD, Inc. 2 variants

Part of a family of 6 devices: see the family page

Ref FFSM-C

Synapse Mobility (FFSM-C) is a device classified as Class IIa in the EU and Class II in the US made by ResolutionMD Inc., registered in EUDAMED on 19 Sep 2023 (Basic UDI-DI ++B037RESMDCXM) and listed in FDA GUDID since 3 Oct 2024 (UDI-DI B037FFSMC0), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID NumberB037FFSMC0 UDI-DI Date3 Oct 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number++B037RESMDCXM Basic UDI-DI B037FFSMC0UDI-DIDate19 Sep 2023RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI ++B037RESMDCXM registered 19 Sep 2023 Active
  • FDA GUDID UDI-DI B037FFSMC0 listed 3 Oct 2024 Listed

Timeline

2 dated events

  1. Registered EUDAMED ++B037RESMDCXM
  2. Listed FDA GUDID B037FFSMC0

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic name
Radiological PACS-dedicated management software
Device name
Radiological Imaging Software
Model / reference
FFSM-C
Primary DI / UDI-DI
B037FFSMC0
Basic UDI-DI
++B037RESMDCXM
FDA product code
LLZ
EMDN code
Z11069092 Various digital bioimaging management instruments - medical device software
GMDN term
Radiological PACS-dedicated management software
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.2050
Special device type
Software
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
CA-MF-000031810
Authorised representative
AR Experts B.V. NL-AR-000023989

Similar devices in this category

Other devices filed under VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE.

Other devices from ResolutionMD Inc.

See all devices from ResolutionMD Inc. →

Properties

  • Measuring function
  • Prescription use
  • Lot / batch number
Other properties (22, all answered No)