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Medws

by MED.e.Com 3 variants

Ref 7.4Model MEDWS

Medws (7.4) is a device classified as Class IIa in the EU and Class II in the US made by Med.e.com, registered in EUDAMED on 23 May 2023 (Basic UDI-DI 3665587DIAGNOSIS0000001LD) with CE/MDR certificate FR25/00000027 valid until 20 Jan 2030, cleared under FDA 510(k) K132684 on 23 May 2014 and listed in FDA GUDID since 27 Mar 2025 (UDI-DI 03665587000149), active as of 22 Oct 2026.

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

CE MDR 510(k)

Valid until

20 Jan 2030

CE MDR certificate

FDA recalls

None found

in data synced 22 Oct 2026

Documents

1 certificate

Certifier SGS Belgium NV

510(k) K132684

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number03665587000149 UDI-DI Date27 Mar 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED NumberFR25/00000027 Date29 Jan 2025IssuedStatusActive expires 20 Jan 2030
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Abbreviated NumberK132684 Date23 May 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 3665587DIAGNOSIS0000001LD registered 23 May 2023 Active· +1 more in the status table
  • FDA 510(k) K132684 decided 23 May 2014 Active
  • FDA GUDID UDI-DI 03665587000149 listed 27 Mar 2025 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • FR25/00000027 Active Amended

    Quality management system EU MDR

    Certifier
    SGS Belgium NV 1639
    Issued
    29 Jan 2025
    Expires
    20 Jan 2030
    Reason
    Mnf ar change

Timeline

5 dated events

  1. Cleared FDA 510(k) K132684
  2. Registered EUDAMED 3665587DIAGNOSIS0000001LD
  3. Certificate issued EUDAMED FR25/00000027
  4. Listed FDA GUDID 03665587000149
  5. Certificate expires EUDAMED FR25/00000027

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Diagnostic x-ray digital imaging system workstation application software
Model / reference
MEDWS, 7.4
Primary DI / UDI-DI
03665587000149
Basic UDI-DI
3665587DIAGNOSIS0000001LD
Direct marketing DI
03665587000149
510(k) Number
FDA product code
LLZ
EMDN code
V92 Medical device software - not included in other classes
GMDN term
Diagnostic x-ray digital imaging system workstation 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
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
FR-MF-000003036

Similar devices in this category

Other devices filed under MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES.

Other devices from Med.e.com

  • Fulgura WS.10.0

    Class IIa

  • Medws

    Class IIa

  • Medws 5.4

    Class II

  • Medws 4.14

    Class II

See all devices from Med.e.com →

Properties

  • Lot / batch number
  • Serial number
Other properties (23, all answered No)