gudid Primary ID: ECG-1112D

Carewell (UDI ECG-1112D)

Manufactured by Shenzhen Carewell Electronics Co., Ltd.

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Carewell (Model/Catalog Number: ECG-1112D) is a medical device manufactured by Shenzhen Carewell Electronics Co., Ltd.. This product is indexed under FDA Product Code / Category Classification DPS within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: ECG-1112D
Product Code / EMDN: DPS
Device Name
Database Sync Date: 2026-08-09 09:06:45

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 Carewell?

The registered manufacturer of record for Carewell is Shenzhen Carewell Electronics Co., Ltd..

What is the Primary UDI-DI identifier for Carewell?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is ECG-1112D.

What classification code is assigned to this device?

This device is registered under product classification code DPS.

Similar Classification Devices (DPS)

Other Devices by Shenzhen Carewell Electronics Co., Ltd.

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