4L (UDI DK10AS)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The 4L (Model/Catalog Number: DK10AS) is a medical device manufactured by 4L Health Co.,Ltd.. This product is indexed under FDA Product Code / Category Classification OMP within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: DK10AS
Product Code / EMDN: OMP
Device Name
Database Sync Date: 2026-08-09 09:05:22

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 4L?

The registered manufacturer of record for 4L is 4L Health Co.,Ltd..

What is the Primary UDI-DI identifier for 4L?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is DK10AS.

What classification code is assigned to this device?

This device is registered under product classification code OMP.

Similar Classification Devices (OMP)

Other Devices by 4L Health Co.,Ltd.

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