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S-Cath™ 5759-L

by Mediplus, Ltd.

Ref 5759-L

S-Cath™ 5759-L is a device classified as Class IIb in the EU and Class II in the US made by Mediplus, Ltd., registered in EUDAMED on 12 Aug 2026 (Basic UDI-DI B-05055140704061), cleared under FDA 510(k) K132890 on 17 Jan 2014 and listed in FDA GUDID since 10 Oct 2025 (UDI-DI 05055140704061), 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-05055140704061 Basic UDI-DI 05055140704061UDI-DIDate12 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055140704061 UDI-DI Date10 Oct 2025ListedStatusListed 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-05055140704061 registered 12 Aug 2026 Active
  • FDA 510(k) K132890 decided 17 Jan 2014 Active
  • FDA GUDID UDI-DI 05055140704061 listed 10 Oct 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K132890
  2. Listed FDA GUDID 05055140704061
  3. Registered EUDAMED B-05055140704061

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  • Withdrawn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
S-Cath™
Generic name
Suprapubic drainage catheter
Model / reference
5759-L
Primary DI / UDI-DI
05055140704061
Basic UDI-DI
B-05055140704061
510(k) Number
FDA product code
KOB
EMDN code
U040102 Kits with drainage catheters and introducers
GMDN term
Suprapubic drainage catheter
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 — 16.0 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

Cleared under the same submission (K132890)

and 8 more cleared under K132890

Similar devices in this category

Other devices filed under KITS WITH DRAINAGE CATHETERS AND INTRODUCERS.

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)