GUDIDData
eudamed_udi Primary ID: 07333387022994

LoFric Sense (UDI 07333387022994)

Manufactured by Wellspect HealthCare

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for LoFric Sense - Primary ID 07333387022994

Device Regulatory Overview

The LoFric Sense (Model/Catalog Number: 4161400) is a medical device manufactured by Wellspect HealthCare. This product is indexed under FDA Product Code / Category Classification U01010501 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
4161400
Product Code / EMDN
U01010501
Device Name
Single use hydrophilic urinary catheter for intermittent urinary catheterization
Database Sync Date
2026-08-09 16:29:32

Full Regulatory Attributes

🔒 Token Gated
{
    "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 LoFric Sense?

The registered manufacturer of record for LoFric Sense is Wellspect HealthCare.

What is the Primary UDI-DI identifier for LoFric Sense?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 07333387022994.

What classification code is assigned to this device?

This device is registered under product classification code U01010501.

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