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SchureMed 800-0116

by Schuerch Corporation

Ref BF578Model Urology Extension

SchureMed 800-0116 is a universal operating table top (EU MDR Class I; FDA Class I; FDA product code FWZ, Operating Room Accessories Table Tray) made by Schuerch Corporation, registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI 0724995MGUROLOGYEXTM5) and listed in FDA GUDID since 11 Jun 2019 (UDI-DI 00724995179793), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0724995MGUROLOGYEXTM5 Basic UDI-DI 00724995179793UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00724995179793 UDI-DI Date11 Jun 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0724995MGUROLOGYEXTM5 registered 29 Oct 2026 Active
  • FDA GUDID UDI-DI 00724995179793 listed 11 Jun 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00724995179793
  2. Registered EUDAMED 0724995MGUROLOGYEXTM5

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  • Withdrawn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
SchureMed
Generic name
Universal operating table top
Device name
Urology Extension
Model / Ref / Catalog
Urology Extension EUDAMED
BF578 EUDAMED
800-0116 GUDID
Primary DI / UDI-DI
00724995179793
Basic UDI-DI
0724995MGUROLOGYEXTM5
FDA product code
FWZ
EMDN code
Z12011299 Patient positioning instruments – other
GMDN term
Universal operating table top
Device class
Class I
Regulation number
878.4950
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Urology Extension
BF578
GUDID
800-0116

Related devices

Category: Universal operating table top

Similar devices in this category

Other devices filed under PATIENT POSITIONING INSTRUMENTS – OTHER.

Other devices from Schuerch Corporation

See all devices from Schuerch Corporation →

Properties

  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)