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Jvc Cl-R211

by Jvc Kenwood Corporation

Ref K/HCTJE405040BModel 21.3-inch (54 cm) Color LCD Monitor

Jvc Cl-R211 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 4975769CL-R211VP), cleared under FDA 510(k) K182539 on 3 Oct 2018 and listed in FDA GUDID since 28 Dec 2018 (UDI-DI 00046838078897), 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) K182539

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 Number4975769CL-R211VP Basic UDI-DI 00046838078897UDI-DIDate14 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00046838078897 UDI-DI Date28 Dec 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK182539 Date3 Oct 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 4975769CL-R211VP registered 14 Apr 2026 Active
  • FDA 510(k) K182539 decided 3 Oct 2018 Active
  • FDA GUDID UDI-DI 00046838078897 listed 28 Dec 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K182539
  2. Listed FDA GUDID 00046838078897
  3. Registered EUDAMED 4975769CL-R211VP

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  • Withdrawn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-R211BN0UA EUDAMED
Jvc GUDID
Generic name
Image display unit, colour
Device name
CL-R211xxxxx
Model / reference
21.3-inch (54 cm) Color LCD Monitor EUDAMED
K/HCTJE405040B EUDAMED
CL-R211 GUDID
Description
2MP Color LCD Monitor CL-R211BN0UA
Primary DI / UDI-DI
00046838078897
Basic UDI-DI
4975769CL-R211VP
510(k) Number
FDA product code
PGY
EMDN code
Z11900802 Bioimaging 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/HCTJE405040B
GUDID
CL-R211
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

Similar devices in this category

Other devices filed under BIOIMAGING 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)