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Jvc Cl-S500

by Jvc Kenwood Corporation 2 variants

Ref K/HCTJE405100BModel 21.3-inch (54 cm) Color LCD Monitor

Jvc Cl-S500 (CL-S500BG2) is a device classified as Class I in the EU and Class II in the US made by Jvc Kenwood Corporation, registered in EUDAMED on 14 Apr 2026 (Basic UDI-DI 4975769CL-S500W8), cleared under FDA 510(k) K191137 on 2 Jul 2019 and listed in FDA GUDID since 20 Jan 2020 (UDI-DI 00046838081026), active as of 24 Oct 2026.

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) K191137

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4975769CL-S500W8 Basic UDI-DI 00046838081026UDI-DIDate14 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00046838081026 UDI-DI Date20 Jan 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK191137 Date2 Jul 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 4975769CL-S500W8 registered 14 Apr 2026 Active
  • FDA 510(k) K191137 decided 2 Jul 2019 Active
  • FDA GUDID UDI-DI 00046838081026 listed 20 Jan 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K191137
  2. Listed FDA GUDID 00046838081026
  3. Registered EUDAMED 4975769CL-S500W8

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  • Withdrawn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
Cl-S500BG2UA EUDAMED
Jvc GUDID
Generic name
Image display unit, colour
Device name
CL-S500xxxxx
Model / Ref / Catalog
21.3-inch (54 cm) Color LCD Monitor EUDAMED
K/HCTJE405100B EUDAMED
CL-S500 GUDID
CL-S500BG2 GUDID
Description
5MP Color LCD Monitor CL-S500BG2UA
Primary DI / UDI-DI
00046838081026
Basic UDI-DI
4975769CL-S500W8
510(k) Number
FDA product code
PGY
EMDN code
Z11900801 Bioimaging diagnostic report viewing monitors
GMDN term
Image display unit, colour
Device class
Class I EUDAMED
Class II GUDID
Regulation number
892.2050
EU registration type
Standard device
EU market of registration
Romania
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
21.3-inch (54 cm) Color LCD Monitor
K/HCTJE405100B
GUDID
CL-S500
Device classEUDAMED
Class I
GUDID
Class II

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

Related devices

Category: Image display unit, colour

Cleared under the same submission (K191137)

Similar devices in this category

Other devices filed under BIOIMAGING DIAGNOSTIC REPORT VIEWING MONITORS.

Other devices from Jvc Kenwood Corporation

  • Jvc Ms-S300

    Class II

  • Jvc Cl-R813

    Class II

  • Jvc Cl-S500

    Class II

  • Jvc Ms-S200

    Class II

See all devices from Jvc Kenwood Corporation →

Properties

  • Serial number
  • Manufacturing date
Other properties (23, all answered No)