eudamed_udi Primary ID: 04745011024213

SHEETSPLINT (UDI 04745011024213)

Manufactured by ETHR OÜ

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

Scannable UDI-DI Representation

Device Regulatory Overview

The SHEETSPLINT (Model/Catalog Number: S032MG1) is a medical device manufactured by ETHR OÜ. This product is indexed under FDA Product Code / Category Classification M03050299 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: S032MG1
Product Code / EMDN: M03050299
Device Name: SHEETSPLINT™ Universal Modular Splint
Database Sync Date: 2026-08-09 16:29:42

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 SHEETSPLINT?

The registered manufacturer of record for SHEETSPLINT is ETHR OÜ.

What is the Primary UDI-DI identifier for SHEETSPLINT?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 04745011024213.

What classification code is assigned to this device?

This device is registered under product classification code M03050299.

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