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Mediplus 5400

by Mediplus, Ltd.

Ref 5400

Mediplus 5400 is a device classified as Class IIa in the EU and Class I in the US made by Mediplus, Ltd., registered in EUDAMED on 11 Aug 2026 (Basic UDI-DI B-05055140701879) and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 05055140701879), active as of 7 Nov 2026.

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

CE MDD

Valid until

No date given

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

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05055140701879 Basic UDI-DI 05055140701879UDI-DIDate11 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055140701879 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-05055140701879 registered 11 Aug 2026 Active
  • FDA GUDID UDI-DI 05055140701879 listed 16 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05055140701879
  2. Registered EUDAMED B-05055140701879

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Mediplus
Generic name
Urodynamic measurement system
Device name
Rectal Catheter, 4.5Fr, sterile
Model / reference
5400
Primary DI / UDI-DI
05055140701879
Basic UDI-DI
B-05055140701879
FDA product code
KGZ
EMDN code
U050401 Intra-abdominal pressure measurement catheters, without balloon
GMDN term
Urodynamic measurement system
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4200
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Length — 200.0 Centimeter
Catheter Gauge — 4.5 French

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

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

Related devices

Category: Urodynamic measurement system

Similar devices in this category

Other devices filed under URODYNAMICS DEVICES.

Other devices from Mediplus, Ltd.

See all devices from Mediplus, Ltd. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (16, all answered No)