eudamed_udi Primary ID: 06957314807525

GMkey (UDI 06957314807525)

Manufactured by Giant Medical Equipment (Guangzhou) Co., Ltd.

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

Scannable UDI-DI Representation

Device Regulatory Overview

The GMkey (Model/Catalog Number: GMH-21224-S) is a medical device manufactured by Giant Medical Equipment (Guangzhou) Co., Ltd.. This product is indexed under FDA Product Code / Category Classification F900201 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: GMH-21224-S
Product Code / EMDN: F900201
Device Name: Hemodialysis Catheter Kits
Database Sync Date: 2026-08-09 16:46:47

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 GMkey?

The registered manufacturer of record for GMkey is Giant Medical Equipment (Guangzhou) Co., Ltd..

What is the Primary UDI-DI identifier for GMkey?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06957314807525.

What classification code is assigned to this device?

This device is registered under product classification code F900201.

Similar Classification Devices (F900201)

Other Devices by Giant Medical Equipment (Guangzhou) Co., Ltd.

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