eudamed_udi Primary ID: 03760124131956

SOPHY® READING INSTRUMENT (UDI 03760124131956)

Manufactured by SOPHYSA

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The SOPHY® READING INSTRUMENT (Model/Catalog Number: SAK-RI) is a medical device manufactured by SOPHYSA. This product is indexed under FDA Product Code / Category Classification N0199 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: SAK-RI
Product Code / EMDN: N0199
Device Name: SOPHY® ADJUSTMENT KIT
Database Sync Date: 2026-08-09 16:30:20

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 SOPHY® READING INSTRUMENT?

The registered manufacturer of record for SOPHY® READING INSTRUMENT is SOPHYSA.

What is the Primary UDI-DI identifier for SOPHY® READING INSTRUMENT?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 03760124131956.

What classification code is assigned to this device?

This device is registered under product classification code N0199.

Similar Classification Devices (N0199)

Other Devices by SOPHYSA

Programmatic Export

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

JSON API Endpoint