gudid Primary ID: 1.0

AssureTech Quick Cup Test (UDI 1.0)

Manufactured by ASSURE TECH. (HANGZHOU) CO., LTD.

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

Scannable UDI-DI Representation

Device Regulatory Overview

The AssureTech Quick Cup Test (Model/Catalog Number: 1.0) is a medical device manufactured by ASSURE TECH. (HANGZHOU) CO., LTD.. This product is indexed under FDA Product Code / Category Classification PTH within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 1.0
Product Code / EMDN: PTH
Device Name: 12 strips, including MOR2000
Database Sync Date: 2026-08-09 09:05:25

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 AssureTech Quick Cup Test?

The registered manufacturer of record for AssureTech Quick Cup Test is ASSURE TECH. (HANGZHOU) CO., LTD..

What is the Primary UDI-DI identifier for AssureTech Quick Cup Test?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 1.0.

What classification code is assigned to this device?

This device is registered under product classification code PTH.

Similar Classification Devices (PTH)

Other Devices by ASSURE TECH. (HANGZHOU) CO., LTD.

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