GUDIDData
eudamed_udi Primary ID: 06936340006195

H FILES (UDI 06936340006195)

Manufactured by Shandong Hengfeng Kerui Medical Equipment Co., Ltd

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for H FILES - Primary ID 06936340006195

Device Regulatory Overview

The H FILES (Model/Catalog Number: SSH 3102 090) is a medical device manufactured by Shandong Hengfeng Kerui Medical Equipment Co., Ltd. This product is indexed under FDA Product Code / Category Classification Q01010299 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
SSH 3102 090
Product Code / EMDN
Q01010299
Device Name
Dental Root Canal Instruments
Database Sync Date
2026-08-09 16:30:04

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 H FILES?

The registered manufacturer of record for H FILES is Shandong Hengfeng Kerui Medical Equipment Co., Ltd.

What is the Primary UDI-DI identifier for H FILES?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06936340006195.

What classification code is assigned to this device?

This device is registered under product classification code Q01010299.

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