gudid
Primary ID: DH-W35-OL
Amico Diagnostic Otoscope (UDI DH-W35-OL)
Manufactured by Amico Diagnostic Incorporated
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Amico Diagnostic Otoscope - Primary ID DH-W35-OL
Device Regulatory Overview
The Amico Diagnostic Otoscope (Model/Catalog Number: DH-W35-OL) is a medical device manufactured by Amico Diagnostic Incorporated. This product is indexed under FDA Product Code / Category Classification ERA within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- DH-W35-OL
- Product Code / EMDN
- ERA
- Device Name
- Operating Otoscope with Specula, LED, Head Only
- Database Sync Date
- 2026-08-09 09:04:19
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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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of Amico Diagnostic Otoscope?
The registered manufacturer of record for Amico Diagnostic Otoscope is Amico Diagnostic Incorporated.
What is the Primary UDI-DI identifier for Amico Diagnostic Otoscope?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is DH-W35-OL.
What classification code is assigned to this device?
This device is registered under product classification code ERA.
Similar Classification Devices (ERA)
Other Devices by Amico Diagnostic Incorporated
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