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Org-9100A

by Nihon Kohden America, Inc.

Org-9100A is a Class II device made by Nihon Kohden America, Inc., listed in FDA GUDID since 19 Sep 2016 (UDI-DI 00841983102554), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00841983102554 UDI-DI Date19 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic name
Electrocardiography monitoring system receiver
Model / Ref / Catalog
ORG-9100A
Primary DI / UDI-DI
00841983102554
FDA product code
DRG
GMDN term
Electrocardiography monitoring system receiver
Device class
Class II
Regulation number
870.2910
GUDID distribution status
Not in Commercial Distribution

Other devices from Nihon Kohden America, Inc.

See all devices from Nihon Kohden America, Inc. →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)