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EAMIS Lite™ EA-RAIL

by Macromedics B.V.

Ref 123110

EAMIS Lite EA-RAIL (123110) is an indexed-immobilization patient positioning system (EU MDR Class I; FDA Class II; FDA product code IYE, Accelerator, Linear, Medical) made by Macromedics B.V., registered in EUDAMED on 2 Jul 2026 (Basic UDI-DI 872016816123110HE), cleared under FDA 510(k) K142420 on 27 Mar 2015 and listed in FDA GUDID since 3 Apr 2017 (UDI-DI 08719425704166), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K142420

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number872016816123110HE Basic UDI-DI 08719425704166UDI-DIDate2 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08719425704166 UDI-DI Date3 Apr 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK142420 Date27 Mar 2015DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 872016816123110HE registered 2 Jul 2026 Active
  • FDA 510(k) K142420 decided 27 Mar 2015 Active
  • FDA GUDID UDI-DI 08719425704166 listed 3 Apr 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K142420
  2. Listed FDA GUDID 08719425704166
  3. Registered EUDAMED 872016816123110HE

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
EAMIS Lite™
Generic name
Indexed-immobilization patient positioning system
Device name
EAMIS Lite
Model / Ref / Catalog
123110, EA-RAIL
Primary DI / UDI-DI
08719425704166
Basic UDI-DI
872016816123110HE
510(k) Number
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 Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
123110
GUDID
EA-RAIL
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

Cleared under the same submission (K142420)

and 8 more cleared under K142420

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
Other properties (23, all answered No)