GUDIDData
eudamed_udi Primary ID: D-XH96

Disposable Autotransfusion System (UDI D-XH96)

Manufactured by Beijing ZKSK Technology Co., Ltd

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Disposable Autotransfusion System - Primary ID D-XH96

Device Regulatory Overview

The Disposable Autotransfusion System (Model/Catalog Number: XH-1000, XH-2000, XH-3000, XH-4000) is a medical device manufactured by Beijing ZKSK Technology Co., Ltd. This product is indexed under FDA Product Code / Category Classification B0499 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
XH-1000, XH-2000, XH-3000, XH-4000
Product Code / EMDN
B0499
Device Name
Disposable Autotransfusion System
Database Sync Date
2026-08-09 16:59:38

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 Disposable Autotransfusion System?

The registered manufacturer of record for Disposable Autotransfusion System is Beijing ZKSK Technology Co., Ltd.

What is the Primary UDI-DI identifier for Disposable Autotransfusion System?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is D-XH96.

What classification code is assigned to this device?

This device is registered under product classification code B0499.

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