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Qlrad 105.1014

by Qlrad International Ltd

Ref 105.1014

Qlrad 105.1014 is a prostate immobilization balloon catheter (EU MDR Class I; FDA Class II; FDA product code PCT, Prostate immobilizer rectal balloon) made by Qlrad International Ltd, registered in EUDAMED on 21 May 2026 (Basic UDI-DI 87193262582105.1014RL), cleared under FDA 510(k) K180478 on 13 Nov 2018 and listed in FDA GUDID since 28 Sep 2020 (UDI-DI 08719326258201), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

510(k) K180478

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number87193262582105.1014RL Basic UDI-DI 08719326258201UDI-DIDate21 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08719326258201 UDI-DI Date28 Sep 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK180478 Date13 Nov 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 87193262582105.1014RL registered 21 May 2026 Active
  • FDA 510(k) K180478 decided 13 Nov 2018 Active
  • FDA GUDID UDI-DI 08719326258201 listed 28 Sep 2020 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

3 dated events

  1. Cleared FDA 510(k) K180478
  2. Listed FDA GUDID 08719326258201
  3. Registered EUDAMED 87193262582105.1014RL

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
RectalPro75 EUDAMED
Qlrad GUDID
Generic name
Prostate immobilization balloon catheter
Model / reference
105.1014
Primary DI / UDI-DI
08719326258201
Basic UDI-DI
87193262582105.1014RL
510(k) Number
FDA product code
PCT
EMDN code
G0301010501 Colonic balloon catheters, low pressure
GMDN term
Prostate immobilization balloon catheter
Device class
Class I EUDAMED
Class II GUDID
Regulation number
892.5720
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

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Prostate immobilization balloon catheter

Cleared under the same submission (K180478)

Similar devices

Also classified as Prostate immobilization balloon catheter.

Similar devices in this category

Other devices filed under GASTROINTESTINAL ENDOSCOPY, BALLOON CATHETERS.

Other devices from Qlrad International Ltd

Properties

  • Single use
  • Reprocessed single-use device
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (20, all answered No)