gudid Primary ID: MECROS E 7S R-312

MIRACLE-EAR (UDI MECROS E 7S R-312)

Manufactured by Starkey Laboratories, Inc.

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

Scannable UDI-DI Representation

Device Regulatory Overview

The MIRACLE-EAR (Model/Catalog Number: MECROS E 7S R-312) is a medical device manufactured by Starkey Laboratories, Inc.. This product is indexed under FDA Product Code / Category Classification KLW within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: MECROS E 7S R-312
Product Code / EMDN: KLW
Device Name
Database Sync Date: 2026-08-09 09:07:49

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 MIRACLE-EAR?

The registered manufacturer of record for MIRACLE-EAR is Starkey Laboratories, Inc..

What is the Primary UDI-DI identifier for MIRACLE-EAR?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is MECROS E 7S R-312.

What classification code is assigned to this device?

This device is registered under product classification code KLW.

Similar Classification Devices (KLW)

Other Devices by Starkey Laboratories, Inc.

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