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Jvc Ms-S300

by Jvc Kenwood Corporation

Ref K/HCTJE405150BModel 21.3-inch (54 cm) Monochrome LCD Monitor

Jvc Ms-S300 is an image display unit (EU MDR Class I; FDA Class II; FDA product code PGY, Display, Diagnostic Radiology) made by Jvc Kenwood Corporation, registered in EUDAMED on 14 Apr 2026 (Basic UDI-DI 4975769MS-S30066), cleared under FDA 510(k) K200161 on 21 Feb 2020 and listed in FDA GUDID since 5 Mar 2020 (UDI-DI 00046838081941), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K200161

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4975769MS-S30066 Basic UDI-DI 00046838081941UDI-DIDate14 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00046838081941 UDI-DI Date5 Mar 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK200161 Date21 Feb 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 4975769MS-S30066 registered 14 Apr 2026 Active
  • FDA 510(k) K200161 decided 21 Feb 2020 Active
  • FDA GUDID UDI-DI 00046838081941 listed 5 Mar 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K200161
  2. Listed FDA GUDID 00046838081941
  3. Registered EUDAMED 4975769MS-S30066

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  • Withdrawn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
Ms-S300BF0UA EUDAMED
Jvc GUDID
Generic name
Image display unit, monochrome
Device name
MS-S300xxxxx
Model / reference
21.3-inch (54 cm) Monochrome LCD Monitor EUDAMED
K/HCTJE405150B EUDAMED
MS-S300 GUDID
Description
3MP Monochrome LCD Monitor MS-S300BF0UA
Primary DI / UDI-DI
00046838081941
Basic UDI-DI
4975769MS-S30066
510(k) Number
FDA product code
PGY
EMDN code
Z11900801 Bioimaging diagnostic report viewing monitors
GMDN term
Image display unit, monochrome
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) Monochrome LCD Monitor
K/HCTJE405150B
GUDID
MS-S300
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, monochrome

Similar devices

Also classified as Image display unit, monochrome.

Similar devices in this category

Other devices filed under BIOIMAGING DIAGNOSTIC REPORT VIEWING MONITORS.

Other devices from Jvc Kenwood Corporation

  • Jvc Cl-R813

    Class II

  • Jvc Cl-S500

    Class II

  • Jvc Ms-S200

    Class II

  • Jvc Cl-S600

    Class II

See all devices from Jvc Kenwood Corporation →

Properties

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