Skip to content

Olympus ISM-1200483

by Gyrus Acmi, Inc.

Ref ISM-1200483

Olympus ISM-1200483 is a device classified as Class I in the EU and Class II in the US made by Gyrus Acmi, Inc., registered in EUDAMED on 6 Oct 2026 (Basic UDI-DI 0821925000615P) and listed in FDA GUDID since 13 Nov 2024 (UDI-DI 00821925046238), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0821925000615P Basic UDI-DI 00821925046238UDI-DIDate6 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00821925046238 UDI-DI Date13 Nov 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0821925000615P registered 6 Oct 2026 Active
  • FDA GUDID UDI-DI 00821925046238 listed 13 Nov 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00821925046238
  2. Registered EUDAMED 0821925000615P

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  • Withdrawn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
Olympus
Generic name
Operating room equipment remote control
Device name
Digital Data Recorders (Video Equipment)
Model / reference
ISM-1200483
Primary DI / UDI-DI
00821925046238
Basic UDI-DI
0821925000615P
FDA product code
FTA
EMDN code
V92 Medical device software - not included in other classes
GMDN term
Operating room equipment remote control
Device class
Class I EUDAMED
Class II GUDID
Regulation number
878.4580
System or procedure pack
System
EU registration type
System or procedure pack
Medical purpose
Dispositif permettant de capturer, de transmettre et de partager des images et des vidéos numériques, destiné au transfert ou à l’échange électronique de données de dispositif médical.
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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: Operating room equipment remote control

Similar devices in this category

Other devices filed under MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES.

Other devices from Gyrus Acmi, Inc.

See all devices from Gyrus Acmi, Inc. →

Properties

  • Prescription use
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)