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Freedom Clear Advantage

by Coloplast A/S 3 variants

Ref 504330, 504310, 504350

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number57089322978429C Basic UDI-DI Date1 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05708932993678 UDI-DI Date6 Dec 2022ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

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

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  • Withdrawn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
Urinary incontinence penis sheath/port, single-use
Device Name
Freedom Clear/Clear Advantage self-sealing urisheath
Model / Ref / Catalog
504330, 504310, 504350
Primary DI / UDI-DI
05708932993678 EUDAMED
05708932993692 EUDAMED
05708932992916 EUDAMED
05708932993647 EUDAMED
05708932992930 EUDAMED
05708932992947 EUDAMED
05701780205382 GUDID
05708932169837 GUDID
05708932169851 GUDID
Basic UDI-DI
57089322978429C
FDA Product Code
NNX
EMDN Code
U070201 Sheath catheter for the treatment of incontinence
GMDN Term
Urinary incontinence penis sheath/port, single-use
Device Class
Class I
Regulation Number
876.5250
EU market of registration
Liechtenstein
Belgium
Germany
Netherlands
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe
Size
Lumen/Inner Diameter — 28 Millimeter
Lumen/Inner Diameter — 1.1 Inch
Lumen/Inner Diameter — 23 Millimeter
Lumen/Inner Diameter — 0.9 Inch
Lumen/Inner Diameter — 1.38 Inch
Lumen/Inner Diameter — 35 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
05708932993678
05708932993692
05708932992916
05708932993647
05708932992930
05708932992947
GUDID
05701780205382
05708932169837
05708932169851

Manufacturer details

EUDAMED SRN
DK-MF-000025526

Other devices from Coloplast A/S

See all devices from Coloplast A/S →

Properties

  • Single Use
  • Over-the-Counter
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • Sterile: No
  • 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
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No