GUDIDData
gudid Primary ID: 27245

27245 (UDI 27245)

Manufactured by Bionix, LLC

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for 27245 - Primary ID 27245

Device Regulatory Overview

The 27245 (Model/Catalog Number: 27245) is a medical device manufactured by Bionix, LLC. This product is indexed under FDA Product Code / Category Classification LRD within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
27245
Product Code / EMDN
LRD
Device Name
Portable Ear Irrigation System (110 v)
Database Sync Date
2026-08-09 09:04:11

Full Regulatory Attributes

🔒 Token Gated
{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}
                            

Unlock Compliance Data & Serialization Specs

Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.

Get API Token Access ($49/mo)

Frequently Asked Questions

Who is the primary manufacturer of 27245?

The registered manufacturer of record for 27245 is Bionix, LLC.

What is the Primary UDI-DI identifier for 27245?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 27245.

What classification code is assigned to this device?

This device is registered under product classification code LRD.

Programmatic Export

Export this master device record as standardized JSON or CSV for compliance audits.

JSON API Endpoint