GUDIDData
eudamed_udi Primary ID: +E308T800207X0G

Helix Test (UDI +E308T800207X0G)

Manufactured by W&H Sterilization Srl

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Helix Test - Primary ID +E308T800207X0G

Device Regulatory Overview

The Helix Test (Model/Catalog Number: T800207X) is a medical device manufactured by W&H Sterilization Srl. This product is indexed under FDA Product Code / Category Classification S9099 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
T800207X
Product Code / EMDN
S9099
Device Name
Helix Test
Database Sync Date
2026-08-09 17:06:49

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 Helix Test?

The registered manufacturer of record for Helix Test is W&H Sterilization Srl.

What is the Primary UDI-DI identifier for Helix Test?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is +E308T800207X0G.

What classification code is assigned to this device?

This device is registered under product classification code S9099.

Programmatic Export

Export this master device record as standardized JSON or CSV for compliance audits.

JSON API Endpoint