GUDIDData
eudamed_udi Primary ID: 09555076115833

Fusione Evolution (UDI 09555076115833)

Manufactured by TERANG NUSA (MALAYSIA) SDN. BHD.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Fusione Evolution - Primary ID 09555076115833

Device Regulatory Overview

The Fusione Evolution (Model/Catalog Number: FSE-507611583) is a medical device manufactured by TERANG NUSA (MALAYSIA) SDN. BHD.. This product is indexed under FDA Product Code / Category Classification T01010203 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
FSE-507611583
Product Code / EMDN
T01010203
Device Name
Sterile Polyisoprene Surgical Powder Free
Database Sync Date
2026-08-09 16:51:53

Full Regulatory Attributes

🔒 Token Gated
{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}
                            

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Frequently Asked Questions

Who is the primary manufacturer of Fusione Evolution?

The registered manufacturer of record for Fusione Evolution is TERANG NUSA (MALAYSIA) SDN. BHD..

What is the Primary UDI-DI identifier for Fusione Evolution?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 09555076115833.

What classification code is assigned to this device?

This device is registered under product classification code T01010203.

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