eudamed_udi
Primary ID: 05404013003570
WM 29083 prismaHYBERNITE (UDI 05404013003570)
Manufactured by Plastiflex Group NV
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for WM 29083
prismaHYBERNITE - Primary ID 05404013003570
Device Regulatory Overview
The WM 29083 prismaHYBERNITE (Model/Catalog Number: HPE15018WT0019GI) is a medical device manufactured by Plastiflex Group NV. This product is indexed under FDA Product Code / Category Classification R02010401 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- HPE15018WT0019GI
- Product Code / EMDN
- R02010401
- Device Name
- Active non implantable respiratory devices.
- Database Sync Date
- 2026-08-09 16:28:55
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 WM 29083 prismaHYBERNITE?
The registered manufacturer of record for WM 29083 prismaHYBERNITE is Plastiflex Group NV.
What is the Primary UDI-DI identifier for WM 29083 prismaHYBERNITE?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 05404013003570.
What classification code is assigned to this device?
This device is registered under product classification code R02010401.
Similar Classification Devices (R02010401)
Other Devices by Plastiflex Group NV
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