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Kenex 354/P76/LED3DF-001

by Kenex (Electro-Medical) Limited EUDAMEDGUDID

Active European Union

Ref 354/P76/LED3DF-001

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number05055449412483 UDI-DIDate4 Jun 2026ListedStatusListed 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  • Withdrawn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 25 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Kenex 76x61cm shield with arm, column& LED 300DF SC lamp EUDAMED
Kenex GUDID
Generic Name
Radiation shielding panel, fixed
Device Name
Overhead suspended radiation shields (with or without lights)
Model / Ref / Catalog
354/P76/LED3DF-001
Primary DI / UDI-DI
05055449412483
Basic UDI-DI
50554494SHOXP
Direct Marketing DI
05055449412483
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
Germany
GUDID distribution status
In Commercial Distribution

Other devices from Kenex (Electro-Medical) Limited

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