GUDIDData
eudamed_udi Primary ID: 06975816761411

Unspecified Brand (UDI 06975816761411)

Manufactured by Xiamen Huakang Orthopedic Co.,Ltd

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Unspecified Brand - Primary ID 06975816761411

Device Regulatory Overview

The Unspecified Brand (Model/Catalog Number: BS008) is a medical device manufactured by Xiamen Huakang Orthopedic Co.,Ltd. This product is indexed under FDA Product Code / Category Classification Y061219 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
BS008
Product Code / EMDN
Y061219
Device Name
Lumbo-Sacral back brace
Database Sync Date
2026-08-09 16:46:11

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 Unspecified Brand?

The registered manufacturer of record for Unspecified Brand is Xiamen Huakang Orthopedic Co.,Ltd.

What is the Primary UDI-DI identifier for Unspecified Brand?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06975816761411.

What classification code is assigned to this device?

This device is registered under product classification code Y061219.

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