eudamed_udi Primary ID: 08055715709306

BIKO XL VERD.DIFF.CAMBIO+CONTROP (UDI 08055715709306)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The BIKO XL VERD.DIFF.CAMBIO+CONTROP (Model/Catalog Number: 05) is a medical device manufactured by ORMESA S.r.l.. This product is indexed under FDA Product Code / Category Classification Y121806 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 05
Product Code / EMDN: Y121806
Device Name: BIKO
Database Sync Date: 2026-08-09 16:28:54

Full Regulatory Attributes

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

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Frequently Asked Questions

Who is the primary manufacturer of BIKO XL VERD.DIFF.CAMBIO+CONTROP?

The registered manufacturer of record for BIKO XL VERD.DIFF.CAMBIO+CONTROP is ORMESA S.r.l..

What is the Primary UDI-DI identifier for BIKO XL VERD.DIFF.CAMBIO+CONTROP?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 08055715709306.

What classification code is assigned to this device?

This device is registered under product classification code Y121806.

Similar Classification Devices (Y121806)

Other Devices by ORMESA S.r.l.

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