eudamed_udi Primary ID: 03760124131642

KIT DE RÉGLAGE-2 POLARIS® (UDI 03760124131642)

Manufactured by SOPHYSA

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

Scannable UDI-DI Representation

Device Regulatory Overview

The KIT DE RÉGLAGE-2 POLARIS® (Model/Catalog Number: PAK2) 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: PAK2
Product Code / EMDN: N0199
Device Name: Polaris® Valve Adjustment kit-2
Database Sync Date: 2026-08-09 16:28:59

Full Regulatory Attributes

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{
    "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 KIT DE RÉGLAGE-2 POLARIS®?

The registered manufacturer of record for KIT DE RÉGLAGE-2 POLARIS® is SOPHYSA.

What is the Primary UDI-DI identifier for KIT DE RÉGLAGE-2 POLARIS®?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 03760124131642.

What classification code is assigned to this device?

This device is registered under product classification code N0199.

Similar Classification Devices (N0199)

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