gudid Primary ID: 8341

Provox Dilator (UDI 8341)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Provox Dilator (Model/Catalog Number: 8341) is a medical device manufactured by Atos Medical AB. This product is indexed under FDA Product Code / Category Classification LRC 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...

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Technical Specifications

Model Number: 8341
Product Code / EMDN: LRC
Device Name
Database Sync Date: 2026-08-09 09:10:28

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 Provox Dilator?

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

What is the Primary UDI-DI identifier for Provox Dilator?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 8341.

What classification code is assigned to this device?

This device is registered under product classification code LRC.

Similar Classification Devices (LRC)

Other Devices by Atos Medical AB

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