GUDIDData
gudid Primary ID: 9782

CONTOURNEXT and MICROLET (UDI 9782)

Manufactured by ASCENSIA DIABETES CARE US INC.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for CONTOURNEXT and MICROLET - Primary ID 9782

Device Regulatory Overview

The CONTOURNEXT and MICROLET (Model/Catalog Number: 9782) is a medical device manufactured by ASCENSIA DIABETES CARE US INC.. This product is indexed under FDA Product Code / Category Classification FMK within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
9782
Product Code / EMDN
FMK
Device Name
Mixed product shipper case containing 1 carton of CONTOURNEXT Blood Glucose Test Strips (Package DI Number 00301937312212) and 100 MICROLET lancets (provided sterile).
Database Sync Date
2026-08-09 09:59:18

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 CONTOURNEXT and MICROLET?

The registered manufacturer of record for CONTOURNEXT and MICROLET is ASCENSIA DIABETES CARE US INC..

What is the Primary UDI-DI identifier for CONTOURNEXT and MICROLET?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 9782.

What classification code is assigned to this device?

This device is registered under product classification code FMK.

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