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Rollator

by Zhejiang Innuovo Rehabilitation Devices Co., Ltd.

Ref W2301Model W2301,W2306,W2501,W2307,W2308,W2308,W2308A,W2309, W2502,W2503,W2505, W2301 W2501 W2502 W2503 W2505 W2306 W2307 W2308 W2308A W2309

Rollator (W2301) is a handgrip disability-assistive walker (EU MDR Class I; FDA Class I; FDA product code ITJ, Walker, Mechanical) made by Zhejiang Innuovo Rehabilitation Devices Co., Ltd., registered in EUDAMED on 8 Aug 2025 (Basic UDI-DI 697894946RL001WC) and listed in FDA GUDID since 13 Aug 2025 (UDI-DI 06978949462385), active as of 8 Nov 2026.

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

CE MDR

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 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06978949462385 UDI-DI Date13 Aug 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number697894946RL001WC Basic UDI-DI Date8 Aug 2025RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 697894946RL001WC registered 8 Aug 2025 Active
  • FDA GUDID UDI-DI 06978949462385 listed 13 Aug 2025 Listed

Timeline

2 dated events

  1. Registered EUDAMED 697894946RL001WC
  2. Listed FDA GUDID 06978949462385

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Handgrip disability-assistive walker, non-powered, foldable
Model / reference
W2301, W2306, W2501, W2307, W2308, W2308A, W2309, W2502, W2503, W2505, W2301 W2501 W2502 W2503 W2505 W2306 W2307 W2308 W2308A W2309
Primary DI / UDI-DI
06978949462385 EUDAMED
06970765974004 EUDAMED
06978949461548 GUDID
Basic UDI-DI
697894946RL001WC, 697076597ROLLATOR001A7
FDA product code
ITJ
EMDN code
Y120606, Y120612
GMDN term
Handgrip disability-assistive walker, non-powered, foldable
Device class
Class I
Regulation number
890.3825
EU registration type
Standard device
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
06978949462385
06970765974004
GUDID
06978949461548

The registries describe this device under different primary UDI-DIs (EUDAMED lists 06978949462385, 06970765974004; FDA GUDID lists 06978949461548), so their flags are not compared.

Manufacturer details

EUDAMED SRN
CN-MF-000008727
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Related devices

Category: Walking chair, non-foldable

Similar devices in this category

Other devices filed under WHEELED WALKER.

Other devices from Zhejiang Innuovo Rehabilitation Devices Co., Ltd.

See all devices from Zhejiang Innuovo Rehabilitation Devices Co., Ltd. →

Properties

  • Over-the-counter
  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)