eudamed_udi Primary ID: 08680757253366

IB-ER (UDI 08680757253366)

Manufactured by IB-ER MAKINA ANONIM SIRKETI

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

Scannable UDI-DI Representation

Device Regulatory Overview

The IB-ER (Model/Catalog Number: OAJ110-20-16R) is a medical device manufactured by IB-ER MAKINA ANONIM SIRKETI. This product is indexed under FDA Product Code / Category Classification Y061299 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: OAJ110-20-16R
Product Code / EMDN: Y061299
Device Name: Orthotic Components
Database Sync Date: 2026-08-09 16:28:46

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 IB-ER?

The registered manufacturer of record for IB-ER is IB-ER MAKINA ANONIM SIRKETI.

What is the Primary UDI-DI identifier for IB-ER?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 08680757253366.

What classification code is assigned to this device?

This device is registered under product classification code Y061299.

Similar Classification Devices (Y061299)

Other Devices by IB-ER MAKINA ANONIM SIRKETI

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