GUDIDData
eudamed_udi Primary ID: 06976753471975

ST2 Assay Reagent Kit (CMIA) PARA DIAGNÓSTICO "IN VITRO" (UDI 06976753471975)

Manufactured by Hangzhou Cybereagen Biotech Co., Ltd.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for ST2 Assay Reagent Kit (CMIA) PARA DIAGNÓSTICO "IN VITRO" - Primary ID 06976753471975

Device Regulatory Overview

The ST2 Assay Reagent Kit (CMIA) PARA DIAGNÓSTICO "IN VITRO" (Model/Catalog Number: C2KL004) is a medical device manufactured by Hangzhou Cybereagen 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
C2KL004
Product Code / EMDN
W01021314
Device Name
C2KL004
Database Sync Date
2026-08-09 18:46:55

Full Regulatory Attributes

🔒 Token Gated
{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}
                            

Unlock Compliance Data & Serialization Specs

Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.

Get API Token Access ($49/mo)

Frequently Asked Questions

Who is the primary manufacturer of ST2 Assay Reagent Kit (CMIA) PARA DIAGNÓSTICO "IN VITRO"?

The registered manufacturer of record for ST2 Assay Reagent Kit (CMIA) PARA DIAGNÓSTICO "IN VITRO" is Hangzhou Cybereagen Biotech Co., Ltd..

What is the Primary UDI-DI identifier for ST2 Assay Reagent Kit (CMIA) PARA DIAGNÓSTICO "IN VITRO"?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06976753471975.

What classification code is assigned to this device?

This device is registered under product classification code W01021314.

Programmatic Export

Export this master device record as standardized JSON or CSV for compliance audits.

JSON API Endpoint