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rShield

by Steris Corporation 2 variants

Ref LB58Model rShield Radiation Protection Device

rShield (LB58) is a Class I device made by Steris Corporation, registered in EUDAMED on 10 Sep 2026 (Basic UDI-DI 0724995MGRSHIELDRPD6Q) and listed in FDA GUDID since 31 Mar 2021 (UDI-DI 00724995153199), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0724995MGRSHIELDRPD6Q Basic UDI-DI 00724995153199UDI-DIDate10 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00724995153199 UDI-DI Date31 Mar 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0724995MGRSHIELDRPD6Q registered 10 Sep 2026 Active
  • FDA GUDID UDI-DI 00724995153199 listed 31 Mar 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00724995153199
  2. Registered EUDAMED 0724995MGRSHIELDRPD6Q

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  • Withdrawn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
Radiation shielding panel, fixed
Device name
rShield Radiation Protection Device
Model / Ref / Catalog
rShield Radiation Protection Device, LB58, rShield
Primary DI / UDI-DI
00724995153199
Basic UDI-DI
0724995MGRSHIELDRPD6Q
FDA product code
EAK
EMDN code
Z12010785 Scialytic lamp lighting systems - consumables
GMDN term
Radiation shielding panel, fixed
Device class
Class I
Regulation number
892.6500
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
rShield Radiation Protection Device
LB58
GUDID
rShield

Similar devices in this category

Other devices filed under SCIALYTIC LAMP LIGHTING SYSTEMS.

Other devices from Steris Corporation

See all devices from Steris Corporation →

Properties

  • Over-the-counter
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)