Néa H2O (UDI 03700659400875)

Manufactured by SEFAM

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Néa H2O (Model/Catalog Number: M-217030-01) is a medical device manufactured by SEFAM. This product is indexed under FDA Product Code / Category Classification R060201 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: M-217030-01
Product Code / EMDN: R060201
Device Name: Néa H2O
Database Sync Date: 2026-08-09 17:22:54

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 Néa H2O?

The registered manufacturer of record for Néa H2O is SEFAM.

What is the Primary UDI-DI identifier for Néa H2O?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 03700659400875.

What classification code is assigned to this device?

This device is registered under product classification code R060201.

Similar Classification Devices (R060201)

Other Devices by SEFAM

Programmatic Export

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

JSON API Endpoint