gudid
Primary ID: U20
CoralView (UDI U20)
Manufactured by MacroLux Medical Technology Co., Ltd.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for CoralView - Primary ID U20
Device Regulatory Overview
The CoralView (Model/Catalog Number: U20) is a medical device manufactured by MacroLux Medical Technology Co., Ltd.. This product is indexed under FDA Product Code / Category Classification FGB within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- U20
- Product Code / EMDN
- FGB
- Device Name
- CoralView, Single-Use Digital Flexible Ureteroscope, U20
- Database Sync Date
- 2026-08-09 09:06:35
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 CoralView?
The registered manufacturer of record for CoralView is MacroLux Medical Technology Co., Ltd..
What is the Primary UDI-DI identifier for CoralView?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is U20.
What classification code is assigned to this device?
This device is registered under product classification code FGB.
Similar Classification Devices (FGB)
Other Devices by MacroLux Medical Technology Co., Ltd.
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint