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RadiForce® RX370A

by Eizo Corporation

Ref RX370AEDBKSI

Withdrawn Withdrawn in European Union.

Was authorized under CE MDR, withdrawn

Ended

Withdrawn

Date not published (CE MDR)

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4995047MonitorVDU2T9 Basic UDI-DI 04995047072676UDI-DIDate30 Jul 2026RegisteredStatusWithdrawn
United StatesGUDID listing GUDID Number04995047072676 UDI-DI Date22 Jul 2026ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Withdrawn
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
RadiForce RX370A-SIBK EUDAMED
RadiForce® GUDID
Generic Name
Image display unit, colour
Device Name
Medical Image Monitor
Model / Ref / Catalog
RX370AEDBKSI EUDAMED
RX370A GUDID
RX370A-SIBK GUDID
Primary DI / UDI-DI
04995047072676
Basic UDI-DI
4995047MonitorVDU2T9
510(k) Number
FDA Product Code
PGY
EMDN Code
Z11900801 Bioimaging diagnostic report viewing monitors
GMDN Term
Image display unit, colour
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.2050
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
RX370AEDBKSI
GUDID
RX370A
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Cleared under the same submission (K211491)

Other devices from Eizo Corporation

See all devices from Eizo Corporation →

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No