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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

Wheeleo-V2 — Class I MDR by InnoRehab

MD Atlas
InnoRehab

EUDAMED last updated this device on Mar 31, 2025

Wheeleo-V2

5430002368WheeleoAX

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: InnoRehab
UDI-DI code: 05430002368009
Reference / catalog number: Wheeleo-V2

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Manufacturer information

Organization name: InnoRehab
SRN: BE-MF-000010049
Manufacturer status: Active

Market distribution

Primary placement in Belgium; available across 1 country total.

Placed on the market in Belgium; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 05430002368009
Basic UDI-DI: 5430002368WheeleoAX
Reference / catalog number: Wheeleo-V2
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: One-handed rollator intended to aid mobility for people with walking difficulties
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y120318QUADRIPODS

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

This device is not currently linked to any other device.

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.