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Qlrad 105.2000

by Qlrad International Ltd

Ref 105.2000

Qlrad 105.2000 is a patient radiation shielding pad/drape (EU MDR Class I; FDA Class I; FDA product code KPY, Shield, Protective, Personnel) made by Qlrad International Ltd, registered in EUDAMED on 22 May 2026 (Basic UDI-DI 87193262582105.2000RG) and listed in FDA GUDID since 1 Apr 2024 (UDI-DI 08720892233004), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number87193262582105.2000RG Basic UDI-DI 08720892233004UDI-DIDate22 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08720892233004 UDI-DI Date1 Apr 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 87193262582105.2000RG registered 22 May 2026 Active
  • FDA GUDID UDI-DI 08720892233004 listed 1 Apr 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08720892233004
  2. Registered EUDAMED 87193262582105.2000RG

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  • Withdrawn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
Skin fold Breast Wedge EUDAMED
Qlrad GUDID
Generic name
Patient radiation shielding pad/drape, reusable
Device name
Breast Wedge
Model / reference
105.2000
Primary DI / UDI-DI
08720892233004
Basic UDI-DI
87193262582105.2000RG
FDA product code
KPY
EMDN code
T030499 Radiotherapy protection devices - other
GMDN term
Patient radiation shielding pad/drape, reusable
Device class
Class I
Regulation number
892.6500
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Related devices

Category: Patient radiation shielding pad/drape, reusable

Similar devices in this category

Other devices filed under RADIOTHERAPY PROTECTION DEVICES - OTHER.

Other devices from Qlrad International Ltd

Properties

  • Reusable
  • Reprocessed single-use device
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)