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STANDY-3 medium

by Ormesa SRL

Ref 23Model STANDY

STANDY-3 medium is a Class I device made by Ormesa SRL, registered in EUDAMED on 21 Jul 2026 (Basic UDI-DI 805571570STANDYMD) and listed in FDA GUDID since 31 Jan 2025 (UDI-DI 08055715705087), 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 Number805571570STANDYMD Basic UDI-DI 08055715705087UDI-DIDate21 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08055715705087 UDI-DI Date31 Jan 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 805571570STANDYMD registered 21 Jul 2026 Active
  • FDA GUDID UDI-DI 08055715705087 listed 31 Jan 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08055715705087
  2. Registered EUDAMED 805571570STANDYMD

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  • Withdrawn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
STANDY-3 medium EUDAMED
Standy GUDID
Generic name
Manual stander
Model / reference
STANDY EUDAMED
23 EUDAMED
STANDY-3 medium GUDID
Primary DI / UDI-DI
08055715705087
Basic UDI-DI
805571570STANDYMD
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
STANDY
23
GUDID
STANDY-3 medium

Related devices

Category: Manual stander

Similar devices

Also classified as Manual stander.

Similar devices in this category

Other devices filed under STANDING FRAMES.

Other devices from Ormesa SRL

See all devices from Ormesa SRL →

Properties

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