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Kenex Centre Mount Shield for Valia Arm

by Kenex (Electro-Medical) Limited EUDAMEDGUDID

Active European Union

Ref 354/P/76-107

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number05055449409933 UDI-DIDate9 Jun 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number50554494SHOXP Basic UDI-DIDate3 Nov 2021RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Kenex Centre Mount Shield for Valia Arm EUDAMED
Kenex GUDID
Generic Name
Radiation shielding panel, fixed
Device Name
Overhead suspended radiation shields (with or without lights)
Model / Ref / Catalog
354/P/76-107
Primary DI / UDI-DI
05055449409933
Basic UDI-DI
50554494SHOXP
Direct Marketing DI
05055449409933
FDA Product Code
EAK
EMDN Code
T0399 Protection devices (excluding personal protective equipment PPE) - other
GMDN Term
Radiation shielding panel, fixed
Device Class
Class I
Regulation Number
892.6500
Market of Registration
France
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
GB-MF-000009022
Authorised representative
Emergo Europe B.V. NL-AR-000000116

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See all devices from Kenex (Electro-Medical) Limited →

Properties

  • Prescription Use
  • Premarket Exempt
  • Serial Number

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No