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Luja Set

by Coloplast A/S 2 variants

Ref 20071

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5708932123295361JW Basic UDI-DIDate19 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05708932785242 UDI-DIDate10 Apr 2026ListedStatusListed GUDID: in commercial distribution

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 found in the data synced 22 Oct 2026.

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  • Withdrawn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

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
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

Manufacturer details

EUDAMED SRN
DK-MF-000025526

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