GUDIDData
gudid Primary ID: FK-127-W-HCGtest

iProvn (UDI FK-127-W-HCGtest)

Manufactured by Masena Invest B.V.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for iProvn - Primary ID FK-127-W-HCGtest

Device Regulatory Overview

The iProvn (Model/Catalog Number: FK-127-W-HCGtest) is a medical device manufactured by Masena Invest B.V.. This product is indexed under FDA Product Code / Category Classification JHI within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
FK-127-W-HCGtest
Product Code / EMDN
JHI
Device Name
HCG strips - pregnancy test strips - REGISTRATION NUMBER HCG STRIP: 21 CFR 862.1155
Database Sync Date
2026-08-09 09:26:45

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 iProvn?

The registered manufacturer of record for iProvn is Masena Invest B.V..

What is the Primary UDI-DI identifier for iProvn?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is FK-127-W-HCGtest.

What classification code is assigned to this device?

This device is registered under product classification code JHI.

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