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312/E Table mounted shields

by Kenex (Electro-Medical) Limited 39 variants

Ref 312/E-013

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number05055449406499 UDI-DI Date8 Dec 2022ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number50554494SHTXZ Basic UDI-DI 05055449406499UDI-DIDate3 Nov 2021RegisteredStatusActive

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.

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  • Withdrawn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
312/E Table mounted shields EUDAMED
Kenex GUDID
Generic Name
Radiation shielding curtain
Device Name
Table mounted radiation shields
Model / Ref / Catalog
312/E-013
Primary DI / UDI-DI
05055449406499
Basic UDI-DI
50554494SHTXZ
FDA Product Code
KPY
EMDN Code
Z11030503 Patient tables for radiological equipment
GMDN Term
Radiation shielding curtain
Device Class
Class I
Regulation Number
892.6500
EU market of registration
Northern Ireland
GUDID distribution status
In Commercial Distribution

Manufacturer details

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

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