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Procure

by ScanMed LLC 2 variants

Ref 588SI3001

Procure (588SI3001) is a device classified as Class IIa in the EU and Class II in the US made by Scanmed, LLC, registered in EUDAMED on 27 Mar 2025 (Basic UDI-DI 0085919300588SI3001ZL) and listed in FDA GUDID since 12 Jan 2017 (UDI-DI 00859193006005), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0085919300588SI3001ZL Basic UDI-DI 00859193006005UDI-DIDate27 Mar 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00859193006005 UDI-DI Date12 Jan 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0085919300588SI3001ZL registered 27 Mar 2025 Active
  • FDA GUDID UDI-DI 00859193006005 listed 12 Jan 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00859193006005
  2. Registered EUDAMED 0085919300588SI3001ZL

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  • Withdrawn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
Procure EUDAMED
ScanMed PROCURE™ Coil GUDID
Generic name
MRI system coil, radio-frequency
Device name
PROCURE 3T Siemens
Model / reference
588SI3001
Primary DI / UDI-DI
00859193006005
Basic UDI-DI
0085919300588SI3001ZL
Direct marketing DI
00859193006005
FDA product code
MOS
EMDN code
Z11059080 Various magnetic resonance imaging instruments - hardware accessories
GMDN term
MRI system coil, radio-frequency
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.1000
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
US-MF-000011107
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Similar devices in this category

Other devices filed under VARIOUS MAGNETIC RESONANCE IMAGING INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Scanmed, LLC

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Properties

  • Prescription use
  • Serial number
Other properties (23, all answered No)