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UniRay UFD42B01

by Uniray Medical LLP

Ref UFD42001Model RADBLOCK

UniRay UFD42B01 is a Class I device made by Uniray Medical LLP, registered in EUDAMED on 28 May 2026 (Basic UDI-DI 89043332RADBLOCKX6) and listed in FDA GUDID since 18 Feb 2023 (UDI-DI 08904333246666), 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 Number89043332RADBLOCKX6 Basic UDI-DI 08904333246666UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08904333246666 UDI-DI Date18 Feb 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 89043332RADBLOCKX6 registered 28 May 2026 Active
  • FDA GUDID UDI-DI 08904333246666 listed 18 Feb 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08904333246666
  2. Registered EUDAMED 89043332RADBLOCKX6

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  • Withdrawn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
UniRay
Generic name
Patient radiation shielding pad/drape, single-use
Device name
Sterile Radiation Shields and Drapes
Model / reference
RADBLOCK EUDAMED
UFD42001 EUDAMED
UFD42B01 GUDID
Description
RadBlock Angiography (Medium)
Primary DI / UDI-DI
08904333246666
Basic UDI-DI
89043332RADBLOCKX6
FDA product code
KPY
EMDN code
T0210 Non-surgical drapes
GMDN term
Patient radiation shielding pad/drape, single-use
Device class
Class I
Regulation number
892.6500
EU registration type
Standard device
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
RADBLOCK
UFD42001
GUDID
UFD42B01

Related devices

Category: Patient radiation shielding pad/drape, single-use

Similar devices in this category

Other devices filed under NON-SURGICAL DRAPES.

Other devices from Uniray Medical LLP

See all devices from Uniray Medical LLP →

Properties

  • Supplied sterile
  • Single use
  • Over-the-counter
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)