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HarmonyAIR A-Series Lighting System

by Steris Corporation 594 variants

Ref LAS13Model HarmonyAIR A-Series Lighting System

HarmonyAIR A-Series Lighting System (LAS13) 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 00724995189976), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0724995MGHAASERLGHTSYS2 Basic UDI-DI 00724995189976UDI-DIDate14 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00724995189976 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 00724995189976 listed 29 May 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00724995189976
  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  • Withdrawn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 system
Model / Ref / Catalog
HarmonyAIR A-Series Lighting System, LAS13, A-Series Lighting System
Primary DI / UDI-DI
00724995189976
Basic UDI-DI
0724995MGHAASERLGHTSYS2
FDA product code
FSY
EMDN code
Z12010701 Fixed scialytic lamps
GMDN term
Operating room light system
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
LAS13
GUDID
A-Series Lighting System
Device classEUDAMED
Class I
GUDID
Class II

Related devices

Category: Operating room light systemOperating room lightMedical monitor/light mount

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)