GUDIDData
gudid Primary ID: SPEEDYBELL

Biopsybell (UDI SPEEDYBELL)

Manufactured by BIOPSYBELL SRL

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Biopsybell - Primary ID SPEEDYBELL

Device Regulatory Overview

The Biopsybell (Model/Catalog Number: SPEEDYBELL) 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
SPEEDYBELL
Product Code / EMDN
FCG
Device Name
Semiautomatic guillotine needle for soft-tissue biopsy
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?

The registered manufacturer of record for Biopsybell is BIOPSYBELL SRL.

What is the Primary UDI-DI identifier for Biopsybell?

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

What classification code is assigned to this device?

This device is registered under product classification code FCG.

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