# Rusch IPN052900

> Active: European Union. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/rusch-662530-000200>
- Manufacturer: [Teleflex Incorporated](https://devicerts.com/manufacturers/teleflex-incorporated) (FDA registration: United States)
- Name in the registry: RUSCH IPN052900
- Device class: Class IIa (EU MDD); Class II (US FDA)
- FDA product code: EZL
- EMDN: U010202 URETHRAL PROSTATIC AND BLADDER CATHETERS, COUVELAIRE, WITH BALLOON
- GMDN: Indwelling urethral drainage balloon catheter, non-antimicrobial (34917)

## Registrations and authorizations

- **EUDAMED** · CE/MDD · European Union · Basic UDI-DI B-04026704069712 · UDI-DI 04026704069712 · registered 2026-07-14 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI 04026704069712 · listed 2020-11-13 · status: Listed (GUDID: in commercial distribution)

## Recalls

No recall on record.

## Identity

- Trade name: SoftSimplastic 2 Way Foley Couvelaire Tip Catheter [EUDAMED]; RUSCH [FDA GUDID (AccessGUDID)]
- Generic name: Indwelling urethral drainage balloon catheter, non-antimicrobial [FDA GUDID (AccessGUDID)]
- Device name: SOFTSIMPLASTIC 2W 30ML COUVELAIRE C [EUDAMED]
- Model / Ref / Catalog: 662530-000200 [EUDAMED, FDA GUDID (AccessGUDID)]; IPN052900 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 04026704069712 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: B-04026704069712 [EUDAMED]
- FDA product code: EZL [FDA GUDID (AccessGUDID)]
- EMDN code: U010202 [EUDAMED]
- GMDN term: Indwelling urethral drainage balloon catheter, non-antimicrobial (34917) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class IIa [EUDAMED]; Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 876.5130 [FDA GUDID (AccessGUDID)]
- EU registration type: Legacy device (under a directive) [EUDAMED]
- EU market of registration: Ireland [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Dimensions & Sizes

- Size: Outer Diameter — 6.7 Millimeter [FDA GUDID (AccessGUDID)]

## Properties

- Supplied sterile: Yes [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: Yes [FDA GUDID (AccessGUDID)]
- Contains latex: Yes [EUDAMED, FDA GUDID (AccessGUDID)]
- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Premarket exempt: Yes [FDA GUDID (AccessGUDID)]
- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Expiration date: Yes [FDA GUDID (AccessGUDID)]
- Manufacturing date: Yes [FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Implantable: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reusable: No [EUDAMED]
- Reprocessed single-use device: No [EUDAMED]
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Contains endocrine-disrupting substances: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Measuring function: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Serial number: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Rusch IPN052900, Teleflex Incorporated. deviCERTS medical device catalogue. https://devicerts.com/devices/rusch-662530-000200 (data as of 2026-11-15).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [EUDAMED](https://ec.europa.eu/tools/eudamed)
- Registry records last synced: 2026-10-23
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/rusch-662530-000200.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/rusch-662530-000200
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.