gudid Primary ID: WFLUAB-OTC-N5

WELLlife (UDI WFLUAB-OTC-N5)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The WELLlife (Model/Catalog Number: WFLUAB-OTC-N5) is a medical device manufactured by WONDFO USA CO., LTD.. This product is indexed under FDA Product Code / Category Classification SCA within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: WFLUAB-OTC-N5
Product Code / EMDN: SCA
Device Name: WELLlife Flu A&B Home Test Cassette, New Package 5 Tests per Kitbox
Database Sync Date: 2026-08-09 09:22:23

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 WELLlife?

The registered manufacturer of record for WELLlife is WONDFO USA CO., LTD..

What is the Primary UDI-DI identifier for WELLlife?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is WFLUAB-OTC-N5.

What classification code is assigned to this device?

This device is registered under product classification code SCA.

Similar Classification Devices (SCA)

Other Devices by WONDFO USA CO., LTD.

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