gudid
Primary ID: Hybernite ROC US
Hybernite (UDI Hybernite ROC US)
Manufactured by Plastiflex Group NV
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Hybernite - Primary ID Hybernite ROC US
Device Regulatory Overview
The Hybernite (Model/Catalog Number: Hybernite ROC US) is a medical device manufactured by Plastiflex Group NV. This product is indexed under FDA Product Code / Category Classification BZE within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- Hybernite ROC US
- Product Code / EMDN
- BZE
- Device Name
- Database Sync Date
- 2026-08-09 09:57:26
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 Hybernite?
The registered manufacturer of record for Hybernite is Plastiflex Group NV.
What is the Primary UDI-DI identifier for Hybernite?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Hybernite ROC US.
What classification code is assigned to this device?
This device is registered under product classification code BZE.
Similar Classification Devices (BZE)
Other Devices by Plastiflex Group NV
Programmatic Export
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