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HarmonyAIR A-Series Camera

by Steris Corporation

Ref LAH00264KModel HarmonyAIR A-Series Camera

HarmonyAIR A-Series Camera (LAH00264K) is a Class I device made by Steris Corporation, registered in EUDAMED on 14 Sep 2026 (Basic UDI-DI 0724995MGHAASERCAMMODJM) and listed in FDA GUDID since 28 Jul 2021 (UDI-DI 00724995201227), 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 Number0724995MGHAASERCAMMODJM Basic UDI-DI 00724995201227UDI-DIDate14 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00724995201227 UDI-DI Date28 Jul 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0724995MGHAASERCAMMODJM registered 14 Sep 2026 Active
  • FDA GUDID UDI-DI 00724995201227 listed 28 Jul 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00724995201227
  2. Registered EUDAMED 0724995MGHAASERCAMMODJM

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  • Withdrawn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
Surgical video camera
Device name
HarmonyAIR A-Series Camera
Model / Ref / Catalog
HarmonyAIR A-Series Camera, LAH00264K, A-Series Camera
Primary DI / UDI-DI
00724995201227
Basic UDI-DI
0724995MGHAASERCAMMODJM
FDA product code
KQM
EMDN code
Z12010799 Scialytic lamp lighting systems - other
GMDN term
Surgical video camera
Device class
Class I
Regulation number
878.4160
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
HarmonyAIR A-Series Camera
LAH00264K
GUDID
A-Series Camera

Related devices

Category: Surgical video camera

Similar devices in this category

Other devices filed under SCIALYTIC LAMP LIGHTING SYSTEMS - OTHER.

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)