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Keyboard Maj-1995

by Olympus Medical Systems Corporation

Ref N4505930

Keyboard Maj-1995 (N4505930) is a device classified as Class I in the EU and Class II in the US made by Olympus Medical Systems Corporation, registered in EUDAMED on 23 Oct 2026 (Basic UDI-DI 495317000202B5), cleared under FDA 510(k) K130058 on 22 Feb 2013 and listed in FDA GUDID since 17 Dec 2021 (UDI-DI 04953170343384), active as of 7 Nov 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 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K130058

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number495317000202B5 Basic UDI-DI 04953170343384UDI-DIDate23 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04953170343384 UDI-DI Date17 Dec 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK130058 Date22 Feb 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 495317000202B5 registered 23 Oct 2026 Active
  • FDA 510(k) K130058 decided 22 Feb 2013 Active
  • FDA GUDID UDI-DI 04953170343384 listed 17 Dec 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K130058
  2. Listed FDA GUDID 04953170343384
  3. Registered EUDAMED 495317000202B5

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  • Withdrawn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
Keyboard Maj-1995 EUDAMED
Keyboard GUDID
Generic name
Computer/medical device keyboard
Device name
Power Cord_VISERA ELITE II
Model / Ref / Catalog
N4505930, MAJ-1995
Primary DI / UDI-DI
04953170343384
Basic UDI-DI
495317000202B5
FDA product code
ODG, ITX, IYN, IYO
EMDN code
Z1104018099 Ultrasound scanners – hardware accessories – other
GMDN term
Computer/medical device keyboard
Device class
Class I EUDAMED
Class II GUDID
Regulation number
876.1500, 892.1570, 892.1550, 892.1560
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
N4505930
GUDID
MAJ-1995
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: Computer/medical device keyboard

Cleared under the same submission (K130058)

Similar devices in this category

Other devices filed under ULTRASOUND SCANNERS – HARDWARE ACCESSORIES – OTHER.

Other devices from Olympus Medical Systems Corporation

See all devices from Olympus Medical Systems Corporation →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)