Organization name

MAD Adam Zdanowicz

SRN

PL-MF-000047582

Manufacturer status

Active

Primary placement in Poland; available across 32 countries total.

Trade name

Ravy S - bicycle for people with dwarfism

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

05908453764010

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

59084537640SML8T

Reference / catalog number

Ravy_S

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

The bicycle for little people was designed and manufactured by MAD Adam Zdanowicz as a result of the project No. POIR.02.03.02-20-0036/20 titled. “AchoBike - Bicycle for little people” subsidized under the Inteligent Development Operational Program, Priority Axis 2 - Supporting the environment and potential of enterprises to carry out R+D+I activities, Measure 2.3 Pro-innovative services for enterprises, Sub-measure 2.3.2 Innovation vouchers for SMEs. Bicycle prototypes were commissioned for special research at the Institute of Innovation and Technology of the Bialystok University of Technology in order to develop bicycles dedicated to little people (including those with various skeletal dysplasias). A specialized research team created the necessary technical and implementation documentation, as well as three variants of bicycles adapted to the three height ranges of people with significantly short stature. As a result of the research work, documentation was created to allow the implementation of bicycles dedicated to people with limited mobility and motor apparatus different from the recognized norm. An impact analysis of prototypes was carried out with the goal of health safety of little people. As a final result of the work, ergonomic prototypes of bicycles adapted to the needs of little people were created: 1.Adapted frame geometry to provide an ergonomic fit for the height, body proportions and physical capabilities of people with significantly short stature, 2.Special drive mechanism adapted to limited limb length, 3.Ergonomic solutions for saddle, pedals and steering improve stability and comfort The forementioned bicycles have a special design to alleviate the difficulties of little people, and are helpful in improving muscle strength, balance and motor function. Through the use of special propulsion mechanisms, stabilizers and unusual frame geometry, they support rehabilitation and improve the function of significantly short people.

Additional information URL

https://shortriders.com/en/

Clinical sizes

• for height up to 100cm (3ft 3,5in)

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Y121801BICYCLES

• Class I medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.