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EagleBoard™ MR

by Macromedics B.V.

Part of a family of 14 devices: see the family page

Ref 122850

EagleBoard™ MR (122850) is a device classified as Class I in the EU and Class II in the US made by Macromedics B.V., registered in EUDAMED on 2 Jul 2026 (Basic UDI-DI 872016816122800J7) and listed in FDA GUDID since 21 Apr 2023 (UDI-DI 08719425704159), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number872016816122800J7 Basic UDI-DI 08719425704159UDI-DIDate2 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08719425704159 UDI-DI Date21 Apr 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 872016816122800J7 registered 2 Jul 2026 Active
  • FDA GUDID UDI-DI 08719425704159 listed 21 Apr 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08719425704159
  2. Registered EUDAMED 872016816122800J7

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  • Withdrawn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

Generic name
Indexed-immobilization patient positioning system
Device name
EagleBoard
Model / Ref / Catalog
122850, EB
Primary DI / UDI-DI
08719425704159
Basic UDI-DI
872016816122800J7
FDA product code
IYE
EMDN code
Z12011280 Patient positioning instruments - hardware accessories
GMDN term
Indexed-immobilization patient positioning system
Device class
Class I EUDAMED
Class II GUDID
Regulation number
892.5050
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
122850
GUDID
EB
Device classEUDAMED
Class I
GUDID
Class II

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

Related devices

Category: Indexed-immobilization patient positioning system

Similar devices in this category

Other devices filed under PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Macromedics B.V.

See all devices from Macromedics B.V. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)