GUDIDData
eudamed_udi Primary ID: 04038953865076

S_ITE QUIX P M N-TAN R BG (UDI 04038953865076)

Manufactured by AS AUDIO-SERVICE GmbH

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for S_ITE QUIX P M N-TAN R BG - Primary ID 04038953865076

Device Regulatory Overview

The S_ITE QUIX P M N-TAN R BG (Model/Catalog Number: 10943623) is a medical device manufactured by AS AUDIO-SERVICE GmbH. This product is indexed under FDA Product Code / Category Classification Y2145060201 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
10943623
Product Code / EMDN
Y2145060201
Device Name
INSTANT FIT
Database Sync Date
2026-08-09 16:45:43

Full Regulatory Attributes

🔒 Token Gated
{
    "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 S_ITE QUIX P M N-TAN R BG?

The registered manufacturer of record for S_ITE QUIX P M N-TAN R BG is AS AUDIO-SERVICE GmbH.

What is the Primary UDI-DI identifier for S_ITE QUIX P M N-TAN R BG?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 04038953865076.

What classification code is assigned to this device?

This device is registered under product classification code Y2145060201.

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