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Grillo

by Ormesa SRL

Part of a family of 72 devices: see the family page

Ref 46Model GRILLO GAIT TRAINER

Grillo is a Class I device made by Ormesa SRL, registered in EUDAMED on 17 Sep 2025 (Basic UDI-DI 805571570GRILLOHD) and listed in FDA GUDID since 25 Aug 2026 (UDI-DI 08054040403187), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08054040403187 UDI-DI Date25 Aug 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number805571570GRILLOHD Basic UDI-DI 08054040403187UDI-DIDate17 Sep 2025RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 805571570GRILLOHD registered 17 Sep 2025 Active
  • FDA GUDID UDI-DI 08054040403187 listed 25 Aug 2026 Listed

Timeline

2 dated events

  1. Registered EUDAMED 805571570GRILLOHD
  2. Listed FDA GUDID 08054040403187

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  • Withdrawn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
FRONT DRIVE GRILLO PA SMALL - with Pelvic Support size MINI and ergonomic Harness size MINI-SMALL EUDAMED
Grillo GUDID
Generic name
Handgrip disability-assistive walker, non-powered, foldable
Model / reference
GRILLO GAIT TRAINER EUDAMED
46 EUDAMED
FRONT DRIVE GRILLO PA SMALL - with Pelvic Support size MINI and ergonomic Harnes GUDID
Primary DI / UDI-DI
08054040403187
Basic UDI-DI
805571570GRILLOHD
FDA product code
ITJ
EMDN code
Y050201 Standing support gait trainers
GMDN term
Handgrip disability-assistive walker, non-powered, foldable
Device class
Class I
Regulation number
890.3825
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
GRILLO GAIT TRAINER
46
GUDID
FRONT DRIVE GRILLO PA SMALL - with Pelvic Support size MINI and ergonomic Harnes

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Other devices filed under STANDING SUPPORT GAIT TRAINERS.

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Properties

  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)