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HarmonyAIR A-Series Lighting System

by Steris Corporation 594 variants

Ref LAH0078Model HarmonyAIR A-Series Lighting System

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0724995MGHAASERLGHTSYS2 Basic UDI-DI 00724995190101UDI-DIDate14 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00724995190101 UDI-DI Date29 May 2020ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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, LAH0078, A-Series Lighting System
Primary DI / UDI-DI
00724995190101
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
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
LAH0078
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 (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No