gudid
Primary ID: RT-181-BL
ROYAL TEK (UDI RT-181-BL)
Manufactured by Surgical Design, Inc.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for ROYAL TEK - Primary ID RT-181-BL
Device Regulatory Overview
The ROYAL TEK (Model/Catalog Number: RT-181-BL) is a medical device manufactured by Surgical Design, Inc.. This product is indexed under FDA Product Code / Category Classification HLJ within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- RT-181-BL
- Product Code / EMDN
- HLJ
- Device Name
- Student Otoscope Set with Replaceable Specula and Extra Bulb - Blue Handle
- Database Sync Date
- 2026-08-09 09:09:58
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 ROYAL TEK?
The registered manufacturer of record for ROYAL TEK is Surgical Design, Inc..
What is the Primary UDI-DI identifier for ROYAL TEK?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is RT-181-BL.
What classification code is assigned to this device?
This device is registered under product classification code HLJ.
Similar Classification Devices (HLJ)
Other Devices by Surgical Design, Inc.
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