GUDIDData
eudamed_udi Primary ID: 05690977250321

AeroFit® Seal-In (UDI 05690977250321)

Manufactured by Össur Iceland ehf.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for AeroFit® Seal-In - Primary ID 05690977250321

Device Regulatory Overview

The AeroFit® Seal-In (Model/Catalog Number: AF-STFS045) is a medical device manufactured by Össur Iceland ehf.. This product is indexed under FDA Product Code / Category Classification Y062499 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
AF-STFS045
Product Code / EMDN
Y062499
Device Name
BU00109
Database Sync Date
2026-08-09 16:28:44

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 AeroFit® Seal-In?

The registered manufacturer of record for AeroFit® Seal-In is Össur Iceland ehf..

What is the Primary UDI-DI identifier for AeroFit® Seal-In?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 05690977250321.

What classification code is assigned to this device?

This device is registered under product classification code Y062499.

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