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SpeediCath Compact 28114

by Coloplast A/S

Ref 28114

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

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 Number57089322978349D Basic UDI-DI 05708932593953UDI-DIDate10 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05708932593953 UDI-DI Date2 Sep 2016ListedStatusListed GUDID: not 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.

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  • Withdrawn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

Trade Name
SpeediCath Compact Eve EUDAMED
SpeediCath Compact GUDID
Generic Name
Single-administration urethral drainage catheter
Device Name
SpeediCath Compact Eve urinary intermittent drainage catheter
Model / Ref / Catalog
28114
Primary DI / UDI-DI
05708932593953 EUDAMED
05708932618779 GUDID
Basic UDI-DI
57089322978349D
Unit of Use DI
05708932593946
FDA Product Code
GBM
EMDN Code
U01010501 Nelaton catheters, self-lubricating
GMDN Term
Single-administration urethral drainage catheter
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
876.5130
EU market of registration
Belgium
GUDID distribution status
Not in Commercial Distribution
Size
Outer Diameter — 4.7 Millimeter
Catheter Gauge — 14 French
Length — 3.25 Inch

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
05708932593953
GUDID
05708932618779
Device ClassEUDAMED
Class I
GUDID
Class II

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Properties

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

Other properties (19)

  • 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
  • Manufacturing Date: No