eudamed_udi Primary ID: 05050962464193

SFB0010EU (UDI 05050962464193)

Manufactured by Helping Hand Company (Ledbury) Ltd

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

Scannable UDI-DI Representation

Device Regulatory Overview

The SFB0010EU (Model/Catalog Number: SFB0010EU) is a medical device manufactured by Helping Hand Company (Ledbury) Ltd. This product is indexed under FDA Product Code / Category Classification V080302 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: SFB0010EU
Product Code / EMDN: V080302
Device Name: PRIMO STARTER PACK EU
Database Sync Date: 2026-08-09 17:12:12

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 SFB0010EU?

The registered manufacturer of record for SFB0010EU is Helping Hand Company (Ledbury) Ltd.

What is the Primary UDI-DI identifier for SFB0010EU?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 05050962464193.

What classification code is assigned to this device?

This device is registered under product classification code V080302.

Similar Classification Devices (V080302)

Other Devices by Helping Hand Company (Ledbury) Ltd

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