GUDIDData
eudamed_udi Primary ID: D-FIHBA-PN20HG5N

HbA1c Control (UDI D-FIHBA-PN20HG5N)

Manufactured by Healgen Scientific Limited Liability Company

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for HbA1c Control - Primary ID D-FIHBA-PN20HG5N

Device Regulatory Overview

The HbA1c Control (Model/Catalog Number: FIHBA-PN20) is a medical device manufactured by Healgen Scientific Limited Liability Company. This product is indexed under FDA Product Code / Category Classification W0101050205 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
FIHBA-PN20
Product Code / EMDN
W0101050205
Device Name
FIHBA-PN20
Database Sync Date
2026-08-09 17:08:07

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 HbA1c Control?

The registered manufacturer of record for HbA1c Control is Healgen Scientific Limited Liability Company.

What is the Primary UDI-DI identifier for HbA1c Control?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is D-FIHBA-PN20HG5N.

What classification code is assigned to this device?

This device is registered under product classification code W0101050205.

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