eudamed_udi
Primary ID: 16923980102667
nProng, #0 (UDI 16923980102667)
Manufactured by GaleMed (Xiamen) Co., Ltd.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for nProng, #0 - Primary ID 16923980102667
Device Regulatory Overview
The nProng, #0 (Model/Catalog Number: AN0054) is a medical device manufactured by GaleMed (Xiamen) Co., Ltd.. This product is indexed under FDA Product Code / Category Classification R02010401 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- AN0054
- Product Code / EMDN
- R02010401
- Device Name
- Disposable Bubble CPAP system
- Database Sync Date
- 2026-08-09 16:51:34
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 nProng, #0?
The registered manufacturer of record for nProng, #0 is GaleMed (Xiamen) Co., Ltd..
What is the Primary UDI-DI identifier for nProng, #0?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 16923980102667.
What classification code is assigned to this device?
This device is registered under product classification code R02010401.
Similar Classification Devices (R02010401)
Other Devices by GaleMed (Xiamen) Co., Ltd.
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