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Medws 4.15

by Med.e.com

Medws 4.15 is a Class II device made by Med.e.com, cleared under FDA 510(k) K132684 on 23 May 2014, registered in EUDAMED and listed in FDA GUDID since 26 Mar 2019 (UDI-DI 03665587000002), active (FDA 510(k), EUDAMED), not in commercial distribution (GUDID) as of 12 Nov 2026.

Active European Union and United States. Also listed in GUDID (US), not in commercial distribution.

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 12 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K132684

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number03665587000002 UDI-DI Date26 Mar 2019ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Abbreviated NumberK132684 Date23 May 2014DecidedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K132684 decided 23 May 2014 Active
  • EUDAMED Active
  • FDA GUDID UDI-DI 03665587000002 listed 26 Mar 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K132684
  2. Listed FDA GUDID 03665587000002

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  • Withdrawn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

Trade name
Medws
Generic name
Diagnostic x-ray digital imaging system workstation application software
Model / reference
4.15
Primary DI / UDI-DI
03665587000002
510(k) Number
FDA product code
LLZ
GMDN term
Diagnostic x-ray digital imaging system workstation application software
Device class
Class II
Regulation number
892.2050
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K132684)

Similar devices

Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).

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 (13, all answered No)