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HexaLux Ceiling Mount

by Steris Corporation

Ref EXLCEILModel HEXALUX Light and Suspension

HexaLux Ceiling Mount (EXLCEIL) is a fixed examination/treatment room light (EU MDR Class I; FDA Class I; FDA product code KZF, Device, medical examination, ac powered) made by Steris Corporation, registered in EUDAMED on 7 Oct 2026 (Basic UDI-DI 0724995MGHEXLUXLGTSPH9) and listed in FDA GUDID since 5 May 2025 (UDI-DI 00724995244286), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0724995MGHEXLUXLGTSPH9 Basic UDI-DI 00724995244286UDI-DIDate7 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00724995244286 UDI-DI Date5 May 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0724995MGHEXLUXLGTSPH9 registered 7 Oct 2026 Active
  • FDA GUDID UDI-DI 00724995244286 listed 5 May 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00724995244286
  2. Registered EUDAMED 0724995MGHEXLUXLGTSPH9

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  • Withdrawn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
HexaLux
Generic name
Fixed examination/treatment room light
Device name
HEXALUX Light and Suspension
Model / Ref / Catalog
HEXALUX Light and Suspension, EXLCEIL, HexaLux Ceiling Mount
Primary DI / UDI-DI
00724995244286
Basic UDI-DI
0724995MGHEXLUXLGTSPH9
FDA product code
KZF
EMDN code
Z12010701 Fixed scialytic lamps
GMDN term
Fixed examination/treatment room light
Device class
Class I
Regulation number
880.6320
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
HEXALUX Light and Suspension
EXLCEIL
GUDID
HexaLux Ceiling Mount

Related devices

Category: Fixed examination/treatment room light

Similar devices in this category

Other devices filed under GENERAL AND MULTIDISCIPLINARY SURGERY INSTRUMENTS.

Other devices from Steris Corporation

See all devices from Steris Corporation →

Properties

  • Over-the-counter
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)