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Luja Set 20074

by Coloplast A/S EUDAMEDGUDID

Active European Union

Ref 20074

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5708932123295361JW Basic UDI-DIDate19 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05708932785303 UDI-DIDate10 Apr 2026ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

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.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 25 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Luja Set
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
20074
Primary DI / UDI-DI
05708932785303 EUDAMED
05708932780827 GUDID
Basic UDI-DI
5708932123295361JW
Unit of Use DI
05708932767293
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
Market of Registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Catheter Gauge — 14 French
Catheter Working Length — 33 Centimeter
Catheter Working Length — 13 Inch

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
05708932785303
GUDID
05708932780827
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Cleared under the same submission (K250270)

Other devices from Coloplast A/S

See all devices from Coloplast A/S →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (18)

  • 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
  • Premarket Exempt: No
  • Serial Number: No