GUDIDData
gudid Primary ID: PT9L

iHealth (UDI PT9L)

Manufactured by iHealth Labs Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for iHealth - Primary ID PT9L

Device Regulatory Overview

The iHealth (Model/Catalog Number: PT9L) is a medical device manufactured by iHealth Labs Inc.. This product is indexed under FDA Product Code / Category Classification SDV within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
PT9L
Product Code / EMDN
SDV
Device Name
Database Sync Date
2026-08-09 09:37:40

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 iHealth?

The registered manufacturer of record for iHealth is iHealth Labs Inc..

What is the Primary UDI-DI identifier for iHealth?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is PT9L.

What classification code is assigned to this device?

This device is registered under product classification code SDV.

Programmatic Export

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