gudid
Primary ID: Black 5mm
Bioclear Evolve (UDI Black 5mm)
Manufactured by Bioclear Matrix Systems
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Bioclear Evolve - Primary ID Black 5mm
Device Regulatory Overview
The Bioclear Evolve (Model/Catalog Number: Black 5mm) is a medical device manufactured by Bioclear Matrix Systems. This product is indexed under FDA Product Code / Category Classification JEP within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- Black 5mm
- Product Code / EMDN
- JEP
- Device Name
- Clear matrix used in dental restorations.
- Database Sync Date
- 2026-08-09 09:01:11
Full Regulatory Attributes
🔒 Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
Unlock Compliance Data & Serialization Specs
Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.
Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of Bioclear Evolve?
The registered manufacturer of record for Bioclear Evolve is Bioclear Matrix Systems.
What is the Primary UDI-DI identifier for Bioclear Evolve?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Black 5mm.
What classification code is assigned to this device?
This device is registered under product classification code JEP.
Similar Classification Devices (JEP)
Other Devices by Bioclear Matrix Systems
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint