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Mini Standy-3

by Ormesa SRL

Ref 29Model MINI-STANDY

Mini Standy-3 is a Class I device made by Ormesa SRL, registered in EUDAMED on 20 Jul 2026 (Basic UDI-DI 805571570STANDYMINISQ) and listed in FDA GUDID since 31 Jan 2025 (UDI-DI 08055715705452), 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 Number805571570STANDYMINISQ Basic UDI-DI 08055715705452UDI-DIDate20 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08055715705452 UDI-DI Date31 Jan 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 805571570STANDYMINISQ registered 20 Jul 2026 Active
  • FDA GUDID UDI-DI 08055715705452 listed 31 Jan 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08055715705452
  2. Registered EUDAMED 805571570STANDYMINISQ

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  • Withdrawn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
Mini Standy-3 EUDAMED
Mini Standy GUDID
Generic name
Manual stander
Device name
Mini-Standy
Model / reference
MINI-STANDY EUDAMED
29 EUDAMED
MINI STANDY-3 GUDID
Primary DI / UDI-DI
08055715705452
Basic UDI-DI
805571570STANDYMINISQ
FDA product code
INM
EMDN code
Y050202 Standing frames
GMDN term
Manual stander
Device class
Class I
Regulation number
890.3100
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
MINI-STANDY
29
GUDID
MINI STANDY-3

Similar devices in this category

Other devices filed under STANDING FRAMES.

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Properties

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