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HarmonyAIR A-Series Lighting System

by Steris Corporation 594 variants

Ref LAS53NCNDModel HarmonyAIR A-Series Lighting System

HarmonyAIR A-Series Lighting System (LAS53NCND) is a device classified as Class I in the EU and Class II in the US made by Steris Corporation, registered in EUDAMED on 14 Sep 2026 (Basic UDI-DI 0724995MGHAASERLGHTSYS2) and listed in FDA GUDID since 29 May 2020 (UDI-DI 00724995189235), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0724995MGHAASERLGHTSYS2 Basic UDI-DI 00724995189235UDI-DIDate14 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00724995189235 UDI-DI Date29 May 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0724995MGHAASERLGHTSYS2 registered 14 Sep 2026 Active
  • FDA GUDID UDI-DI 00724995189235 listed 29 May 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00724995189235
  2. Registered EUDAMED 0724995MGHAASERLGHTSYS2

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  • Withdrawn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
HarmonyAIR
Generic name
Operating room light
Model / Ref / Catalog
HarmonyAIR A-Series Lighting System, LAS53NCND, A-Series Lighting System
Primary DI / UDI-DI
00724995189235
Basic UDI-DI
0724995MGHAASERLGHTSYS2
FDA product code
FSY
EMDN code
Z12010701 Fixed scialytic lamps
GMDN term
Operating room light
Device class
Class I EUDAMED
Class II GUDID
Regulation number
878.4580
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
HarmonyAIR A-Series Lighting System
LAS53NCND
GUDID
A-Series Lighting System
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 light systemOperating room lightMedical monitor/light mount

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Other devices filed under GENERAL AND MULTIDISCIPLINARY SURGERY INSTRUMENTS.

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Properties

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