Wellell (UDI WiZARD 510)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Wellell (Model/Catalog Number: WiZARD 510) is a medical device manufactured by Wellell Inc.. This product is indexed under FDA Product Code / Category Classification BZD within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: WiZARD 510
Product Code / EMDN: BZD
Device Name: WiZARD 510 Nasal Mask L Size
Database Sync Date: 2026-08-09 09:00:28

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 Wellell?

The registered manufacturer of record for Wellell is Wellell Inc..

What is the Primary UDI-DI identifier for Wellell?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is WiZARD 510.

What classification code is assigned to this device?

This device is registered under product classification code BZD.

Similar Classification Devices (BZD)

Other Devices by Wellell Inc.

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