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External table top control unit 115084D0

by Maquet, Inc.

Ref 115084D0

External table top control unit 115084D0 is a Class I device made by Maquet, Inc., registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI 40467680112FBD) and listed in FDA GUDID since 22 Sep 2022 (UDI-DI 04046768040557), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number40467680112FBD Basic UDI-DI 04046768040557UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04046768040557 UDI-DI Date22 Sep 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 40467680112FBD registered 29 Oct 2026 Active
  • FDA GUDID UDI-DI 04046768040557 listed 22 Sep 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04046768040557
  2. Registered EUDAMED 40467680112FBD

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  • Withdrawn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
External table top control unit
Generic name
Operating room equipment remote control
Device name
Hand control table top
Model / reference
115084D0
Primary DI / UDI-DI
04046768040557
Basic UDI-DI
40467680112FBD
FDA product code
JEA
EMDN code
Z12011202 Operating tables
GMDN term
Operating room equipment remote control
Device class
Class I
Regulation number
878.4960
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Related devices

Category: Operating room equipment remote control

Similar devices in this category

Other devices filed under OPERATING TABLES.

Other devices from Maquet, Inc.

See all devices from Maquet, Inc. →

Properties

  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)