Home GUDID 08054040401985 BIKO
Primary DI 08054040401985
Brand BIKO
Company ORMESA SRL
Model BIKO XL BLU DIFFERENZ.SWITCH
Device description Medical device intended for children/teens/adults who have knowledge of the space around them, who are able to pedal and who have minimal control of the head and trunk. In addition, upper extremity motor control is required to properly steer the handlebars. Even those who have difficulty controlling their balance during the journey will be able to benefit from the use of the tricycle thanks to the stability offered by the whole system.
Published 2026-08-01
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name ION Exerciser, Non-Measuring
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ION Exerciser, Non-Measuring Physical Medicine 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08054040401985 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08054040401985 08054040401985 8054040401985
GMDN Terms# Term, Definition table Term Definition Assistive foot-propelled tricycle A vehicle with three wheels mounted on a slender frame which the user with a disability sits astride and pedals with their legs to provide a means of transportation, typically without the attendance of another person. It is designed to be operated by the user. The vehicle will enhance the user's independence in short- to medium-range transportation.
Regulatory Flags# DUNS number 432070019 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number true Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 08055715701454 JUDITTA JUDITTA-36 B30 LIGHT GREY, BLACK FRAME 2025-01-31 08055715701461 JUDITTA JUDITTA-36 B30 DARK GREY, BLACK FRAME 2025-01-31 08055715701478 JUDITTA JUDITTA-36 B30 LIGHT GREY, WHITE FRAME 2025-01-31 08055715701485 JUDITTA JUDITTA-36 B30 DARK GREY, WHITE FRAME 2025-01-31 08055715701492 JUDITTA JUDITTA-40 B30 LIGHT GREY, BLACK FRAME 2025-01-31 08055715701508 JUDITTA JUDITTA-40 B30 DARK GREY, BLACK FRAME 2025-01-31 08055715701515 JUDITTA JUDITTA-40 B30 LIGHT GREY, WHITE FRAME 2025-01-31 08055715701522 JUDITTA JUDITTA-40 B30 DARK GREY, WHITE FRAME 2025-01-31 08055715701539 JUDITTA JUDITTA-45 B30 LIGHT GREY, BLACK FRAME 2025-01-31 08055715701546 JUDITTA JUDITTA-45 B30 DARK GREY, BLACK FRAME 2025-01-31 08055715701553 JUDITTA JUDITTA-45 B30 LIGHT GREY, WHITE FRAME 2025-01-31 08055715701560 JUDITTA JUDITTA-45 B30 DARK GREY, WHITE FRAME 2025-01-31 08055715701577 JUDITTA JUDITTA-50 B30 LIGHT GREY, BLACK FRAME 2025-01-31 08055715701584 JUDITTA JUDITTA-50 B30 DARK GREY, BLACK FRAME 2025-01-31 08055715701591 JUDITTA JUDITTA-50 B30 LIGHT GREY, WHITE FRAME 2025-01-31 08055715701607 JUDITTA JUDITTA-50 B30 DARK GREY, WHITE FRAME 2025-01-31 08055715701935 JUDITTA JUDITTA-36 B60 LIGHT GREY, BLACK FRAME 2025-01-31 08055715701942 JUDITTA JUDITTA-36 B60 DARK GREY, BLACK FRAME 2025-01-31 08055715701959 JUDITTA JUDITTA-36 B60 LIGHT GREY, WHITE FRAME 2025-01-31 08055715701966 JUDITTA JUDITTA-36 B60 DARK GREY, WHITE FRAME 2025-01-31
Other Devices Sharing Product Codes#