gudid Primary ID: 8025

Provox Luna Set (UDI 8025)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Provox Luna Set (Model/Catalog Number: 8025) is a medical device manufactured by Atos Medical AB. This product is indexed under FDA Product Code / Category Classification BYD within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 1 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-1548-2021 View Full Alert →

Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and moisture exchangers for patients breathing through a trac...

🔒 Compromised Lot & Serial Numbers Locked

Verify if facility inventory is affected by this recall.

Unlock Lot Data ($49)

Technical Specifications

Model Number: 8025
Product Code / EMDN: BYD
Device Name: The Provox Luna Set is a combination of Provox Luna HME and Provox Luna Adhesive.Provox Luna HME:The Provox Luna HME is a single use heat- and moisture exchanger, attachable to the Provox Luna Adhesive, for night-time use after total laryngectomy.Provox Luna Adhesive:The Provox Luna Adhesive is a skin friendly, single use adhesive that provides attachment for the Provox Luna HME for night time use after total laryngectomy.
Database Sync Date: 2026-08-09 09:10:28

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 Provox Luna Set?

The registered manufacturer of record for Provox Luna Set is Atos Medical AB.

What is the Primary UDI-DI identifier for Provox Luna Set?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 8025.

What classification code is assigned to this device?

This device is registered under product classification code BYD.

Similar Classification Devices (BYD)

Other Devices by Atos Medical AB

Programmatic Export

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

JSON API Endpoint