GUDIDData
gudid Primary ID: 0565

Otoferm Creme (UDI 0565)

Manufactured by Dreve Otoplastik GmbH

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Otoferm Creme - Primary ID 0565

Device Regulatory Overview

The Otoferm Creme (Model/Catalog Number: 0565) is a medical device manufactured by Dreve Otoplastik GmbH. This product is indexed under FDA Product Code / Category Classification KMJ within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
0565
Product Code / EMDN
KMJ
Device Name
No.
Database Sync Date
2026-08-09 09:07:33

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 Otoferm Creme?

The registered manufacturer of record for Otoferm Creme is Dreve Otoplastik GmbH.

What is the Primary UDI-DI identifier for Otoferm Creme?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 0565.

What classification code is assigned to this device?

This device is registered under product classification code KMJ.

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