GUDIDData
gudid Primary ID: 20346

Com-Fit (UDI 20346)

Manufactured by Sultan Healthcare Inc

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Com-Fit - Primary ID 20346

Device Regulatory Overview

The Com-Fit (Model/Catalog Number: 20346) is a medical device manufactured by Sultan Healthcare Inc. This product is indexed under FDA Product Code / Category Classification FXX within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
20346
Product Code / EMDN
FXX
Device Name
Super Sensitive com-fit mask Earloop Box of 50
Database Sync Date
2026-08-09 09:03:02

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 Com-Fit?

The registered manufacturer of record for Com-Fit is Sultan Healthcare Inc.

What is the Primary UDI-DI identifier for Com-Fit?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 20346.

What classification code is assigned to this device?

This device is registered under product classification code FXX.

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