HarmonyAIR

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref LAH56NC02TModel HarmonyAIR A-Series Lighting System

by Steris Corporation

Identity

Trade Name: HarmonyAIR EUDAMEDFDA UDI
Generic Name: Operating room light system FDA UDI
Transportable medical equipment stand, non-powered FDA UDI
Device Name: HarmonyAIR A-Series Lighting System EUDAMED
The A-Series Hybrid High Density Single Light, Dual Monitor Mount 75-inch Light, 67-inch Dual Monitor Mount, 20-inch Drop Tube, No Controller, Tandem is used with the HarmonyAIR A-Series Lighting System. FDA UDI
The A-Series High Density Mobile Light is used with the HarmonyAIR A-Series Lighting System. FDA UDI
Model / Reference: HarmonyAIR A-Series Lighting System EUDAMED
LAH56NC02T EUDAMED
A-Series Lighting System FDA UDI
A-Series Mobile Light FDA UDI
Description: The A-Series Hybrid High Density Single Light, Dual Monitor Mount 75-inch Light, 67-inch Dual Monitor Mount, 20-inch Drop Tube, No Controller, Tandem is used with the HarmonyAIR A-Series Lighting System. FDA UDI
The A-Series High Density Mobile Light is used with the HarmonyAIR A-Series Lighting System. FDA UDI

Identifiers

Catalog Number: LAH56NC02T FDA UDI
LAH0055 FDA UDI
Primary DI / UDI-DI: 00724995187965 EUDAMEDFDA UDI
00724995190002 FDA UDI
Basic UDI-DI: 0724995MGHAASERLGHTSYS2 EUDAMED
FDA Product Code: FSY FDA UDI
FSS FDA UDI
EMDN Code: Z12010701 FIXED SCIALYTIC LAMPS EUDAMED
GMDN Term: Operating room light system FDA UDI
Transportable medical equipment stand, non-powered FDA UDI

Classification

Device Class: Class I EUDAMED
Class II FDA UDI
Regulation Number: 878.4580 FDA UDI
Market of Registration: Ireland EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Operating room light system Operating room light Medical monitor/light mount

HarmonyAIR by Steris Corporation — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

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Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Steris Corporation

Sources (3)

FDA UDI d8218625-deb5-4ccd-b97b-7ea7963e6bca 35 fields · synced Sep 17, 2026
FDA UDI f888c6d2-d5fc-4a0a-ba96-0d949f748203 35 fields · synced May 25, 2026
EUDAMED 4ba68285-9903-4262-8ca0-4a67410b1491 61 fields · synced Sep 17, 2026