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Gloreha Aria 1

by Idrogenet Srl

Ref GAR

Gloreha Aria 1 (GAR) is a virtual-display rehabilitation system (EU MDR Class I; FDA Class I; FDA product code ION, Exerciser, Non-Measuring) made by Idrogenet Srl, registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI 805571376GARLC) and listed in FDA GUDID since 4 Nov 2024 (UDI-DI 08055713760033), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number805571376GARLC Basic UDI-DI 08055713760033UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08055713760033 UDI-DI Date4 Nov 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 805571376GARLC registered 6 Nov 2026 Active
  • FDA GUDID UDI-DI 08055713760033 listed 4 Nov 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08055713760033
  2. Registered EUDAMED 805571376GARLC

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  • Withdrawn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
Gloreha Aria
Generic name
Virtual-display rehabilitation system, passive-support, upper-limb
Model / Ref / Catalog
GAR, 1
Primary DI / UDI-DI
08055713760033
Basic UDI-DI
805571376GARLC
FDA product code
ION
EMDN code
Z12069099 Various physiotherapy and rehabilitation instruments - other
GMDN term
Virtual-display rehabilitation system, passive-support, upper-limb
Device class
Class I
Regulation number
890.5370
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
GAR
GUDID
1

Related devices

Category: Virtual-display rehabilitation system, passive-support, upper-limb

Similar devices in this category

Other devices filed under VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - OTHER.

Other devices from Idrogenet Srl

Properties

  • Premarket exempt
  • Lot / batch number
  • Serial number
Other properties (22, all answered No)