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Sim&Size

by Sim&Cure 3 variants

Ref 1.2

Sim&Size (1.2) is a device classified as Class IIa in the EU and Class II in the US made by Sim&Cure, registered in EUDAMED on 4 Nov 2024 (Basic UDI-DI B-03665786000032), cleared under FDA 510(k) K222664 on 27 Jan 2023 and listed in FDA GUDID since 14 Mar 2023 (UDI-DI 03665786000032), active as of 25 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K222664

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-03665786000032 Basic UDI-DI 03665786000032UDI-DIDate4 Nov 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number03665786000032 UDI-DI Date14 Mar 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK222664 Date27 Jan 2023IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-03665786000032 registered 4 Nov 2024 Active
  • FDA 510(k) K222664 decided 27 Jan 2023 Active
  • FDA GUDID UDI-DI 03665786000032 listed 14 Mar 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K222664
  2. Listed FDA GUDID 03665786000032
  3. Registered EUDAMED B-03665786000032

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
Radiology DICOM image processing application software
Model / reference
1.2 EUDAMED
V1.2 GUDID
Primary DI / UDI-DI
03665786000032
Basic UDI-DI
B-03665786000032
510(k) Number
FDA product code
PZO
EMDN code
Z11030592 Radiology instruments - medical device software
GMDN term
Radiology DICOM image processing application software
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.2050
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
1.2
GUDID
V1.2
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
FR-MF-000000319

Similar devices in this category

Other devices filed under RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE.

Other devices from Sim&Cure

See all devices from Sim&Cure →

Properties

  • Measuring function
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)