GUDIDData
eudamed_udi Primary ID: 06973600799817

INNODX ST2 STAT CMIA (UDI 06973600799817)

Manufactured by Xiamen Innodx Biotech Co., Ltd.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for INNODX ST2 STAT CMIA - Primary ID 06973600799817

Device Regulatory Overview

The INNODX ST2 STAT CMIA (Model/Catalog Number: KR-ST2 STAT-05100) is a medical device manufactured by Xiamen Innodx Biotech Co., Ltd.. This product is indexed under FDA Product Code / Category Classification W01021314 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
KR-ST2 STAT-05100
Product Code / EMDN
W01021314
Device Name
INNODX ST2 STAT CMIA
Database Sync Date
2026-08-09 18:43:10

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 INNODX ST2 STAT CMIA?

The registered manufacturer of record for INNODX ST2 STAT CMIA is Xiamen Innodx Biotech Co., Ltd..

What is the Primary UDI-DI identifier for INNODX ST2 STAT CMIA?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06973600799817.

What classification code is assigned to this device?

This device is registered under product classification code W01021314.

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