BIOPSYBELL SRL (UDI ORION EXPLANT)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The BIOPSYBELL SRL (Model/Catalog Number: ORION EXPLANT) is a medical device manufactured by BIOPSYBELL SRL. This product is indexed under FDA Product Code / Category Classification FCG within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: ORION EXPLANT
Product Code / EMDN: FCG
Device Name: NEEDLE FOR BONE MARROW EXPLANT
Database Sync Date: 2026-08-09 09:04:33

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 BIOPSYBELL SRL?

The registered manufacturer of record for BIOPSYBELL SRL is BIOPSYBELL SRL.

What is the Primary UDI-DI identifier for BIOPSYBELL SRL?

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

What classification code is assigned to this device?

This device is registered under product classification code FCG.

Similar Classification Devices (FCG)

Other Devices by BIOPSYBELL SRL

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