ADS (UDI ACA5)

Manufactured by Guangzhou Ajax Medical Equipment Co., Ltd.

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

Scannable UDI-DI Representation

Device Regulatory Overview

The ADS (Model/Catalog Number: ACA5) is a medical device manufactured by Guangzhou Ajax Medical Equipment Co., Ltd.. This product is indexed under FDA Product Code / Category Classification FLE within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: ACA5
Product Code / EMDN: FLE
Device Name
Database Sync Date: 2026-08-09 09:06:43

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 ADS?

The registered manufacturer of record for ADS is Guangzhou Ajax Medical Equipment Co., Ltd..

What is the Primary UDI-DI identifier for ADS?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is ACA5.

What classification code is assigned to this device?

This device is registered under product classification code FLE.

Similar Classification Devices (FLE)

Other Devices by Guangzhou Ajax Medical Equipment Co., Ltd.

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