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Gloreha Active Package 1

by Idrogenet Srl

Ref GAP

Gloreha Active Package 1 (GAP) is a virtual-display rehabilitation system (EU MDD Class IIa; FDA Class I; FDA product code BXB, Exerciser, Powered) made by Idrogenet Srl, registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI B-08055713760026) and listed in FDA GUDID since 4 Nov 2024 (UDI-DI 08055713760026), active as of 7 Nov 2026.

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

CE MDD

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/MDD EUDAMED NumberB-08055713760026 Basic UDI-DI 08055713760026UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08055713760026 UDI-DI Date4 Nov 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08055713760026 registered 6 Nov 2026 Active
  • FDA GUDID UDI-DI 08055713760026 listed 4 Nov 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08055713760026
  2. Registered EUDAMED B-08055713760026

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Gloreha Active Package
Generic name
Virtual-display rehabilitation system, powered-support, upper-limb
Model / Ref / Catalog
GAP, 1
Primary DI / UDI-DI
08055713760026
Basic UDI-DI
B-08055713760026
FDA product code
BXB
EMDN code
Z120616 Electromechanical systems for physical therapy
GMDN term
Virtual-display rehabilitation system, powered-support, upper-limb
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
890.5380
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
GAP
GUDID
1
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

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

Similar devices in this category

Other devices filed under ELECTROMECHANICAL SYSTEMS FOR PHYSICAL THERAPY.

Other devices from Idrogenet Srl

Properties

  • Premarket exempt
  • Lot / batch number
  • Serial number
Other properties (20, all answered No)