GUDIDData
eudamed_udi Primary ID: 05056111340141

Apollo PLUS Fiber Optic Universal EENT Diagnostic Set Complete Including 1 x Otoscope Head, 1 x Ophthalmoscope Head, 1 x Battery Handle, 1 x Nasal Illuminator, 1 x Straight Illuminator, 1 x Plain Mirror 20 mm, 1 x Tongue Depressor, 1 x 1Reusable Ear Specu (UDI 05056111340141)

Manufactured by Surtex Instruments Ltd

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Apollo PLUS Fiber Optic Universal EENT Diagnostic Set Complete Including 1 x Otoscope Head, 1 x Ophthalmoscope Head, 1 x Battery Handle, 1 x Nasal Illuminator, 1 x Straight Illuminator, 1 x Plain Mirror 20 mm, 1 x Tongue Depressor, 1 x 1Reusable Ear Specu - Primary ID 05056111340141

Device Regulatory Overview

The Apollo PLUS Fiber Optic Universal EENT Diagnostic Set Complete Including 1 x Otoscope Head, 1 x Ophthalmoscope Head, 1 x Battery Handle, 1 x Nasal Illuminator, 1 x Straight Illuminator, 1 x Plain Mirror 20 mm, 1 x Tongue Depressor, 1 x 1Reusable Ear Specu (Model/Catalog Number: DI-760-00) is a medical device manufactured by Surtex Instruments Ltd. This product is indexed under FDA Product Code / Category Classification Z12149006 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
DI-760-00
Product Code / EMDN
Z12149006
Device Name
Diagnostic Instruments
Database Sync Date
2026-08-09 16:28:44

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 Apollo PLUS Fiber Optic Universal EENT Diagnostic Set Complete Including 1 x Otoscope Head, 1 x Ophthalmoscope Head, 1 x Battery Handle, 1 x Nasal Illuminator, 1 x Straight Illuminator, 1 x Plain Mirror 20 mm, 1 x Tongue Depressor, 1 x 1Reusable Ear Specu?

The registered manufacturer of record for Apollo PLUS Fiber Optic Universal EENT Diagnostic Set Complete Including 1 x Otoscope Head, 1 x Ophthalmoscope Head, 1 x Battery Handle, 1 x Nasal Illuminator, 1 x Straight Illuminator, 1 x Plain Mirror 20 mm, 1 x Tongue Depressor, 1 x 1Reusable Ear Specu is Surtex Instruments Ltd.

What is the Primary UDI-DI identifier for Apollo PLUS Fiber Optic Universal EENT Diagnostic Set Complete Including 1 x Otoscope Head, 1 x Ophthalmoscope Head, 1 x Battery Handle, 1 x Nasal Illuminator, 1 x Straight Illuminator, 1 x Plain Mirror 20 mm, 1 x Tongue Depressor, 1 x 1Reusable Ear Specu?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 05056111340141.

What classification code is assigned to this device?

This device is registered under product classification code Z12149006.

Programmatic Export

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

JSON API Endpoint