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CuratOR MIR-1

by Eizo Corporation 2 variants

Part of a family of 7 devices: see the family page

Ref MIR1USZZ

CuratOR MIR-1 is a Class I device made by Eizo Corporation, registered in EUDAMED on 25 Aug 2026 (Basic UDI-DI 4995047Recorder2Y) and listed in FDA GUDID since 29 Aug 2024 (UDI-DI 04995047068570), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4995047Recorder2Y Basic UDI-DI 04995047068570UDI-DIDate25 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04995047068570 UDI-DI Date29 Aug 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4995047Recorder2Y registered 25 Aug 2026 Active
  • FDA GUDID UDI-DI 04995047068570 listed 29 Aug 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04995047068570
  2. Registered EUDAMED 4995047Recorder2Y

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
CuratOR MIR-1 EUDAMED
CuratOR GUDID
Generic name
Medical video image recorder
Device name
Medical Image Recorder
Model / Ref / Catalog
MIR1USZZ EUDAMED
MIR-1 GUDID
Primary DI / UDI-DI
04995047068570
Basic UDI-DI
4995047Recorder2Y
FDA product code
LMB
EMDN code
Z119014 Video recorders for bioimages
GMDN term
Medical video image recorder
Device class
Class I
Regulation number
892.2010
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
MIR1USZZ
GUDID
MIR-1

Related devices

Category: Medical video image recorder

Similar devices in this category

Other devices filed under VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS.

Other devices from Eizo Corporation

See all devices from Eizo Corporation →

Properties

  • Prescription use
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)