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Su-2000

by SHINYOUNG FOR M Co., Ltd.

Su-2000 is a radiological general body-part positioner (EU MDD Class I; FDA Class I; FDA product code IXY, Holder, Radiographic Cassette, Wall-Mounted) made by Shinyoung for M Co., Ltd., registered in EUDAMED on 10 Sep 2024 (Basic UDI-DI B-08809832900166) and listed in FDA GUDID since 20 Nov 2023 (UDI-DI 08809832900166), active as of 22 Oct 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08809832900166 Basic UDI-DI 08809832900166UDI-DIDate10 Sep 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number08809832900166 UDI-DI Date20 Nov 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08809832900166 registered 10 Sep 2024 Active
  • FDA GUDID UDI-DI 08809832900166 listed 20 Nov 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08809832900166
  2. Registered EUDAMED B-08809832900166

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  • Withdrawn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

Generic name
Radiological general body-part positioner
Model / reference
SU-2000_V1
Primary DI / UDI-DI
08809832900166
Basic UDI-DI
B-08809832900166
FDA product code
IXY
EMDN code
Z11039080 Various radiodiagnostic and interventional instruments - hardware accessories
GMDN term
Radiological general body-part positioner
Device class
Class I
Regulation number
892.1880
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
KR-MF-000043632
Authorised representative
Obelis s.a. BE-AR-000000106

Similar devices in this category

Other devices filed under VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Shinyoung for M Co., Ltd.

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Properties

  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)