gudid Primary ID: ROLLER 10 PLUS NEEDLE

ROLLER 10 PLUS NEEDLE (UDI ROLLER 10 PLUS NEEDLE)

Manufactured by ALIFAX SRL

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

Scannable UDI-DI Representation

Device Regulatory Overview

The ROLLER 10 PLUS NEEDLE (Model/Catalog Number: ROLLER 10 PLUS NEEDLE) is a medical device manufactured by ALIFAX SRL. This product is indexed under FDA Product Code / Category Classification GKB within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: ROLLER 10 PLUS NEEDLE
Product Code / EMDN: GKB
Device Name
Database Sync Date: 2026-08-09 09:04:30

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 ROLLER 10 PLUS NEEDLE?

The registered manufacturer of record for ROLLER 10 PLUS NEEDLE is ALIFAX SRL.

What is the Primary UDI-DI identifier for ROLLER 10 PLUS NEEDLE?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is ROLLER 10 PLUS NEEDLE.

What classification code is assigned to this device?

This device is registered under product classification code GKB.

Similar Classification Devices (GKB)

Other Devices by ALIFAX SRL

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