eudamed_udi Primary ID: D-CoV2-107A

SARS-CoV-2 Test (UDI D-CoV2-107A)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The SARS-CoV-2 Test (Model/Catalog Number: CoV2-10) is a medical device manufactured by FlashDx Shenzhen Inc. This product is indexed under FDA Product Code / Category Classification W0105070503 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: CoV2-10
Product Code / EMDN: W0105070503
Device Name: SARS-CoV-2 Test
Database Sync Date: 2026-08-09 16:44:51

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 SARS-CoV-2 Test?

The registered manufacturer of record for SARS-CoV-2 Test is FlashDx Shenzhen Inc.

What is the Primary UDI-DI identifier for SARS-CoV-2 Test?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is D-CoV2-107A.

What classification code is assigned to this device?

This device is registered under product classification code W0105070503.

Similar Classification Devices (W0105070503)

Other Devices by FlashDx Shenzhen Inc

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