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
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
}
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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.
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Programmatic Export
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