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Rusch IPN052900

by Teleflex Incorporated

Ref 662530-000200

Rusch IPN052900 (662530-000200) is an indwelling urethral drainage balloon catheter (EU MDD Class IIa; FDA Class II; FDA product code EZL, Catheter, Retention Type, Balloon) made by Teleflex Incorporated, registered in EUDAMED on 14 Jul 2026 (Basic UDI-DI B-04026704069712) and listed in FDA GUDID since 13 Nov 2020 (UDI-DI 04026704069712), active as of 23 Oct 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04026704069712 Basic UDI-DI 04026704069712UDI-DIDate14 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04026704069712 UDI-DI Date13 Nov 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04026704069712 registered 14 Jul 2026 Active
  • FDA GUDID UDI-DI 04026704069712 listed 13 Nov 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04026704069712
  2. Registered EUDAMED B-04026704069712

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  • Withdrawn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
SoftSimplastic 2 Way Foley Couvelaire Tip Catheter EUDAMED
Rusch GUDID
Generic name
Indwelling urethral drainage balloon catheter, non-antimicrobial
Device name
Softsimplastic 2W 30ml Couvelaire C
Model / Ref / Catalog
662530-000200, IPN052900
Primary DI / UDI-DI
04026704069712
Basic UDI-DI
B-04026704069712
FDA product code
EZL
EMDN code
U010202 Urethral prostatic and bladder catheters, couvelaire, with balloon
GMDN term
Indwelling urethral drainage balloon catheter, non-antimicrobial
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.5130
EU registration type
Legacy device (under a directive)
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 6.7 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
662530-000200
GUDID
IPN052900
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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

Similar devices in this category

Other devices filed under URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON.

Other devices from Teleflex Incorporated

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  • Arrow IPNB00826 Open recall

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See all devices from Teleflex Incorporated →

Properties

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