Bionova (UDI KPCD220-C)
Manufactured by TERRAGENE S.A.
Device Regulatory Overview
The Bionova (Model/Catalog Number: KPCD220-C) is a medical device manufactured by TERRAGENE S.A.. This product is indexed under FDA Product Code / Category Classification FRC within international Unique Device Identification (UDI) compliance databases.
Enforcement actions are currently active for this product line.
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Technical Specifications
- Model Number
- KPCD220-C
- Product Code / EMDN
- FRC
- Device Name
- Steam Test Pack PCD Kit (25 test packs and 25 control BIs)
- Database Sync Date
- 2026-08-09 09:07:23
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 Bionova?
The registered manufacturer of record for Bionova is TERRAGENE S.A..
What is the Primary UDI-DI identifier for Bionova?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is KPCD220-C.
What classification code is assigned to this device?
This device is registered under product classification code FRC.
Similar Classification Devices (FRC)
Other Devices by TERRAGENE S.A.
Programmatic Export
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JSON API Endpoint