GUDIDData
eudamed_udi Primary ID: 08800111723117

STANDARD™ M10 C. difficile BT (UDI 08800111723117)

Manufactured by SD Biosensor Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for STANDARD™ M10 C. difficile BT - Primary ID 08800111723117

Device Regulatory Overview

The STANDARD™ M10 C. difficile BT (Model/Catalog Number: 11CDC20A) is a medical device manufactured by SD Biosensor Inc.. This product is indexed under FDA Product Code / Category Classification W0105011804 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
11CDC20A
Product Code / EMDN
W0105011804
Device Name
STANDARD™ M10 C. difficile BT
Database Sync Date
2026-08-09 17:45:13

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 STANDARD™ M10 C. difficile BT?

The registered manufacturer of record for STANDARD™ M10 C. difficile BT is SD Biosensor Inc..

What is the Primary UDI-DI identifier for STANDARD™ M10 C. difficile BT?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 08800111723117.

What classification code is assigned to this device?

This device is registered under product classification code W0105011804.

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