# Rollator

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

- Canonical page: <https://devicerts.com/devices/rollator-w2301>
- Manufacturer: [Zhejiang Innuovo Rehabilitation Devices Co., Ltd.](https://devicerts.com/manufacturers/zhejiang-innuovo-rehabilitation-devices-coltd) (China)
- Device class: Class I (EU MDR / US FDA)
- FDA product code: ITJ
- EMDN: Y120606 WHEELED WALKER
- EMDN: Y120612 WALKING TROLLEYS
- GMDN: Handgrip disability-assistive walker, non-powered, foldable (37951)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI 06978949462385 · listed 2025-08-13 · status: Listed (GUDID: in commercial distribution)
- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI 697894946RL001WC · registered 2025-08-08 · status: Active

## Recalls

No recall on record.

## Identity

- Generic name: Handgrip disability-assistive walker, non-powered, foldable [FDA GUDID (AccessGUDID)]
- Model / reference: W2301 [EUDAMED, FDA GUDID (AccessGUDID)]; W2306 [EUDAMED]; W2501 [EUDAMED]; W2307 [EUDAMED]; W2308 [EUDAMED]; W2308A [EUDAMED]; W2309 [EUDAMED]; W2502 [EUDAMED]; W2503 [EUDAMED]; W2505 [EUDAMED]; W2301 W2501 W2502 W2503 W2505 W2306 W2307 W2308 W2308A W2309 [EUDAMED]

## Identifiers

- Primary DI / UDI-DI: 06978949462385 [EUDAMED]; 06970765974004 [EUDAMED]; 06978949461548 [FDA GUDID (AccessGUDID)]
- Basic UDI-DI: 697894946RL001WC [EUDAMED]; 697076597ROLLATOR001A7 [EUDAMED]
- FDA product code: ITJ [FDA GUDID (AccessGUDID)]
- EMDN code: Y120606 [EUDAMED]; Y120612 [EUDAMED]
- GMDN term: Handgrip disability-assistive walker, non-powered, foldable (37951) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class I [EUDAMED, FDA GUDID (AccessGUDID)]
- Regulation number: 890.3825 [FDA GUDID (AccessGUDID)]
- EU registration type: Standard device [EUDAMED]
- EU market of registration: Austria [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Over-the-counter: Yes [FDA GUDID (AccessGUDID)]
- Premarket exempt: Yes [FDA GUDID (AccessGUDID)]
- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Serial number: Yes [FDA GUDID (AccessGUDID)]
- Expiration date: Yes [FDA GUDID (AccessGUDID)]
- Manufacturing date: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reusable: No [EUDAMED]
- Contains latex: No [EUDAMED, FDA GUDID (AccessGUDID)]
- 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]
- Prescription use: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Rollator, Zhejiang Innuovo Rehabilitation Devices Co., Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/rollator-w2301 (data as of 2026-11-15).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/)
- Registry records last synced: 2026-11-08
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/rollator-w2301.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/rollator-w2301
- 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.