GUDIDData
eudamed_udi Primary ID: 04057155000764

SpiroSphere (UDI 04057155000764)

Manufactured by eResearchTechnology GmbH

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for SpiroSphere - Primary ID 04057155000764

Device Regulatory Overview

The SpiroSphere (Model/Catalog Number: 151260) is a medical device manufactured by eResearchTechnology GmbH. This product is indexed under FDA Product Code / Category Classification Z12150101 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
151260
Product Code / EMDN
Z12150101
Device Name
SpiroSphere
Database Sync Date
2026-08-09 16:58:54

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 SpiroSphere?

The registered manufacturer of record for SpiroSphere is eResearchTechnology GmbH.

What is the Primary UDI-DI identifier for SpiroSphere?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 04057155000764.

What classification code is assigned to this device?

This device is registered under product classification code Z12150101.

Programmatic Export

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

JSON API Endpoint