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HarmonyAIR M-Series Suspension

by Steris Corporation 2 variants

Ref LMH0010Model M-Series Camera

HarmonyAIR M-Series Suspension (LMH0010) is a Class I device made by Steris Corporation, registered in EUDAMED on 10 Sep 2026 (Basic UDI-DI 0724995MGMSERCAMERAYF) and listed in FDA GUDID since 15 May 2020 (UDI-DI 00724995158408), 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 Number0724995MGMSERCAMERAYF Basic UDI-DI 00724995158408UDI-DIDate10 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00724995158408 UDI-DI Date15 May 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0724995MGMSERCAMERAYF registered 10 Sep 2026 Active
  • FDA GUDID UDI-DI 00724995158408 listed 15 May 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00724995158408
  2. Registered EUDAMED 0724995MGMSERCAMERAYF

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  • Withdrawn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
M-Series Camera
Model / Ref / Catalog
M-Series Camera, LMH0010, M-Series Suspension
Primary DI / UDI-DI
00724995158408
Basic UDI-DI
0724995MGMSERCAMERAYF
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
M-Series Camera
LMH0010
GUDID
M-Series Suspension

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)