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Luja Set

by Coloplast A/S 2 variants

Part of a family of 8 devices: see the family page

Ref 20071

Luja Set (20071) is a device classified as Class I in the EU and Class II in the US made by Coloplast A/S, registered in EUDAMED on 19 Jun 2026 (Basic UDI-DI 5708932123295361JW), cleared under FDA 510(k) K250270 on 17 Apr 2025 and listed in FDA GUDID since 10 Apr 2026 (UDI-DI 05708932785242), active as of 22 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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K250270

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5708932123295361JW Basic UDI-DI 05708932785242UDI-DIDate19 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05708932785242 UDI-DI Date10 Apr 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK250270 Date17 Apr 2025DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 5708932123295361JW registered 19 Jun 2026 Active
  • FDA 510(k) K250270 decided 17 Apr 2025 Active
  • FDA GUDID UDI-DI 05708932785242 listed 10 Apr 2026 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K250270
  2. Listed FDA GUDID 05708932785242
  3. Registered EUDAMED 5708932123295361JW

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  • Withdrawn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

Generic name
Single-administration urethral catheterization kit, single-use
Device name
Luja Set male urinary intermittent drainage catheter with integrated urine bag
Model / Ref / Catalog
20071
Primary DI / UDI-DI
05708932785242 EUDAMED
05708932780766 GUDID
Basic UDI-DI
5708932123295361JW
Unit of use DI
05708932767279
510(k) Number
FDA product code
EZD
EMDN code
A06030301, U01010501
GMDN term
Single-administration urethral catheterization kit, single-use
Device class
Class I EUDAMED
Class II GUDID
Regulation number
876.5130
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Catheter Working Length — 13 Inch
Catheter Working Length — 33 Centimeter
Catheter Gauge — 10 French

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
05708932785242
GUDID
05708932780766
Device classEUDAMED
Class I
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 05708932785242; FDA GUDID lists 05708932780766), so their flags are not compared. 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.

Manufacturer details

EUDAMED SRN
DK-MF-000025526

Similar devices in this category

Other devices filed under URINE COLLECTION BAGS.

Other devices from Coloplast A/S

See all devices from Coloplast A/S →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)