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Sim&Size

by Sim&Cure 3 variants

Ref 2.0

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K253122↗

+5 more

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k) 510(k) NumberK253122 Date23 Dec 2025IssuedStatusActive
United StatesGUDID listing GUDID Number03665786000070 UDI-DI Date11 Feb 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number3665786S&SV2ZW Basic UDI-DI 03665786000070UDI-DIDate15 Nov 2024RegisteredStatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K253122 decided 23 Dec 2025 Active· +5 more in the status table
  • EUDAMED Basic UDI-DI 3665786S&SV2ZW registered 15 Nov 2024 Active
  • FDA GUDID UDI-DI 03665786000070 listed 11 Feb 2025 Listed

Timeline

8 dated events

  1. Cleared FDA 510(k) K190049
  2. Cleared FDA 510(k) K202322
  3. Cleared FDA 510(k) K212373
  4. Cleared FDA 510(k) K222664
  5. Registered EUDAMED 3665786S&SV2ZW
  6. Cleared FDA 510(k) K242124
  7. Listed FDA GUDID 03665786000070
  8. Cleared FDA 510(k) K253122

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Generic name
Radiology DICOM image processing application software
Model / reference
2.0 EUDAMED
V2.0 GUDID
Primary DI / UDI-DI
03665786000070
Basic UDI-DI
3665786S&SV2ZW
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
Special device type
Software
EU registration type
Standard device
EU market of registration
Finland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
2.0
GUDID
V2.0
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

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Sim&Size is a measuring device (Nomenclature Code: Z11030592) designed for dimensional assessment, likely in a clinical or training context. Classified as a Class IIa medical device, it incorporates active components to facilitate precise measurements, though it is not intended for implant, reprocessing, or administration of medicines.

Supplied as a non-sterile, single-use device (Reference: 2.0), Sim&Size is intended for use in environments requiring accurate dimensional verification without the need for sterilisation. Authorised under FDA 510K and MDR, it adheres to standard regulatory criteria and carries a Basic UDI (3665786S&SV2ZW) for traceability. No latex, animal, or human tissue components are present, ensuring compatibility with common patient sensitivities.

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 (21, all answered No)