eudamed_udi Primary ID: 06942007314411

R-Shaper Files (UDI 06942007314411)

Manufactured by Shenzhen Rogin Medical Co., Ltd

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

Scannable UDI-DI Representation

Device Regulatory Overview

The R-Shaper Files (Model/Catalog Number: R-P.01.06-025-04-015-GD-000-00-00) is a medical device manufactured by Shenzhen Rogin Medical Co., Ltd. This product is indexed under FDA Product Code / Category Classification Q010507 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: R-P.01.06-025-04-015-GD-000-00-00
Product Code / EMDN: Q010507
Device Name: R-Shaper Files
Database Sync Date: 2026-08-09 16:28:47

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 R-Shaper Files?

The registered manufacturer of record for R-Shaper Files is Shenzhen Rogin Medical Co., Ltd.

What is the Primary UDI-DI identifier for R-Shaper Files?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06942007314411.

What classification code is assigned to this device?

This device is registered under product classification code Q010507.

Similar Classification Devices (Q010507)

Other Devices by Shenzhen Rogin Medical Co., Ltd

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