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Image Receptor Protector

by Reina Imaging

Ref Image Receptor Protector

Image Receptor Protector is a stationary x-ray grid (EU MDR Class I; FDA Class I; FDA product code IXY, Holder, Radiographic Cassette, Wall-Mounted) made by Reina Imaging, registered in EUDAMED on 17 Nov 2022 (Basic UDI-DI 08600017001IRProtector52) and listed in FDA GUDID since 29 Oct 2019 (UDI-DI 00860001700183), 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 Number08600017001IRProtector52 Basic UDI-DI 00860001700183UDI-DIDate17 Nov 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number00860001700183 UDI-DI Date29 Oct 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08600017001IRProtector52 registered 17 Nov 2022 Active
  • FDA GUDID UDI-DI 00860001700183 listed 29 Oct 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00860001700183
  2. Registered EUDAMED 08600017001IRProtector52

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  • Withdrawn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
Image Receptor Protector EUDAMED
Protect-A-Grid GUDID
Generic name
Stationary x-ray grid
Model / Ref / Catalog
Image Receptor Protector EUDAMED
P[2][X]DR[NG][Y] GUDID
Premium Grid Encasement GUDID
Primary DI / UDI-DI
00860001700183
Basic UDI-DI
08600017001IRProtector52
FDA product code
IXY
EMDN code
Z110310 Multifunctional systems for traditional radiology
GMDN term
Stationary x-ray grid
Device class
Class I
Regulation number
892.1880
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Image Receptor Protector
GUDID
P[2][X]DR[NG][Y]

Manufacturer details

EUDAMED SRN
US-MF-000008652
Authorised representative
Meddevices Lifesciences B.V. NL-AR-000000594

Similar devices in this category

Other devices filed under MULTIFUNCTIONAL SYSTEMS FOR TRADITIONAL RADIOLOGY.

Other devices from Reina Imaging

Properties

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