eudamed_udi Primary ID: 06971792052215

Insulin (INS) Assay Reagent Kit (CMIA) (UDI 06971792052215)

Manufactured by Hangzhou Realy Tech Co.,Ltd.

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The Insulin (INS) Assay Reagent Kit (CMIA) (Model/Catalog Number: C2KG002) is a medical device manufactured by Hangzhou Realy Tech Co.,Ltd.. This product is indexed under FDA Product Code / Category Classification W0102060103 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: C2KG002
Product Code / EMDN: W0102060103
Device Name: C2KG002
Database Sync Date: 2026-08-09 18:00:12

Full Regulatory Attributes

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{
    "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 Insulin (INS) Assay Reagent Kit (CMIA)?

The registered manufacturer of record for Insulin (INS) Assay Reagent Kit (CMIA) is Hangzhou Realy Tech Co.,Ltd..

What is the Primary UDI-DI identifier for Insulin (INS) Assay Reagent Kit (CMIA)?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06971792052215.

What classification code is assigned to this device?

This device is registered under product classification code W0102060103.

Similar Classification Devices (W0102060103)

Other Devices by Hangzhou Realy Tech Co.,Ltd.

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