gudid
Primary ID: HO35
SeleneView (UDI HO35)
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 SeleneView - Primary ID HO35
Device Regulatory Overview
The SeleneView (Model/Catalog Number: HO35) is a medical device manufactured by MacroLux Medical Technology Co., Ltd.. This product is indexed under FDA Product Code / Category Classification HIH within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- HO35
- Product Code / EMDN
- HIH
- Device Name
- SeleneView, Single-Use Digital Hysteroscope, HO35
- Database Sync Date
- 2026-08-09 09:06:35
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 SeleneView?
The registered manufacturer of record for SeleneView is MacroLux Medical Technology Co., Ltd..
What is the Primary UDI-DI identifier for SeleneView?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is HO35.
What classification code is assigned to this device?
This device is registered under product classification code HIH.
Similar Classification Devices (HIH)
Other Devices by MacroLux Medical Technology Co., Ltd.
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