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Mediplus 5765

by Mediplus, Ltd.

Ref 5765

Mediplus 5765 is a device classified as Class IIb in the EU and Class II in the US made by Mediplus, Ltd., registered in EUDAMED on 14 Aug 2026 (Basic UDI-DI B-05055140701602), cleared under FDA 510(k) K132890 on 17 Jan 2014 and listed in FDA GUDID since 17 Oct 2015 (UDI-DI 05055140701602), active as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K132890

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05055140701602 Basic UDI-DI 05055140701602UDI-DIDate14 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055140701602 UDI-DI Date17 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK132890 Date17 Jan 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-05055140701602 registered 14 Aug 2026 Active
  • FDA 510(k) K132890 decided 17 Jan 2014 Active
  • FDA GUDID UDI-DI 05055140701602 listed 17 Oct 2015 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K132890
  2. Listed FDA GUDID 05055140701602
  3. Registered EUDAMED B-05055140701602

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Mediplus
Generic name
Indwelling urethral drainage balloon catheter, non-antimicrobial
Device name
Silicone 2 Way Foley (open tip) Catheter, 12Fr. 10cc, Standard, 42cm
Model / reference
5765
Description
Silicone 2 way Foley (open tip) catheter , 12Fr, standard
Primary DI / UDI-DI
05055140701602
Basic UDI-DI
B-05055140701602
510(k) Number
FDA product code
KOB
EMDN code
U040199 Devices for suprapubic urinary drainage - other
GMDN term
Indwelling urethral drainage balloon catheter, non-antimicrobial
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
876.5090
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Length — 42.0 Centimeter
Catheter Gauge — 12.0 French

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Indwelling urethral drainage balloon catheter, non-antimicrobial

Cleared under the same submission (K132890)

and 8 more cleared under K132890

Similar devices in this category

Other devices filed under DEVICES FOR SUPRAPUBIC URINARY DRAINAGE - OTHER.

Other devices from Mediplus, Ltd.

See all devices from Mediplus, Ltd. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)