gudid Primary ID: BIKO SMALL ROSSO PIGN. FISSO

BIKO (UDI BIKO SMALL ROSSO PIGN. FISSO)

Manufactured by ORMESA SRL

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The BIKO (Model/Catalog Number: BIKO SMALL ROSSO PIGN. FISSO) is a medical device manufactured by ORMESA SRL. This product is indexed under FDA Product Code / Category Classification ION within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: BIKO SMALL ROSSO PIGN. FISSO
Product Code / EMDN: ION
Device Name: 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.
Database Sync Date: 2026-08-09 09:04:30

Full Regulatory Attributes

🔒 Token Gated

{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

Unlock Compliance Data & Serialization Specs

Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.

Get API Token Access ($49/mo)

Frequently Asked Questions

Who is the primary manufacturer of BIKO?

The registered manufacturer of record for BIKO is ORMESA SRL.

What is the Primary UDI-DI identifier for BIKO?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is BIKO SMALL ROSSO PIGN. FISSO.

What classification code is assigned to this device?

This device is registered under product classification code ION.

Similar Classification Devices (ION)

Other Devices by ORMESA SRL

Programmatic Export

Export this master device record as standardized JSON or CSV for compliance audits.

JSON API Endpoint