GUDIDData
eudamed_udi Primary ID: 08800111724022

Unspecified Brand (UDI 08800111724022)

Manufactured by SD Biosensor Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Unspecified Brand - Primary ID 08800111724022

Device Regulatory Overview

The Unspecified Brand (Model/Catalog Number: 16E210F) is a medical device manufactured by SD Biosensor Inc.. This product is indexed under FDA Product Code / Category Classification W0102050103 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
16E210F
Product Code / EMDN
W0102050103
Device Name
STANDARDâ„¢ i E2
Database Sync Date
2026-08-09 18:19:10

Full Regulatory Attributes

đŸ”’ 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 Unspecified Brand?

The registered manufacturer of record for Unspecified Brand is SD Biosensor Inc..

What is the Primary UDI-DI identifier for Unspecified Brand?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 08800111724022.

What classification code is assigned to this device?

This device is registered under product classification code W0102050103.

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