GUDIDData
eudamed_udi Primary ID: 07611600996865

DermaPlast ACTIVE Coolfix (UDI 07611600996865)

Manufactured by IVF HARTMANN AG

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for DermaPlast ACTIVE Coolfix - Primary ID 07611600996865

Device Regulatory Overview

The DermaPlast ACTIVE Coolfix (Model/Catalog Number: 522013) is a medical device manufactured by IVF HARTMANN AG. This product is indexed under FDA Product Code / Category Classification M03040299 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
522013
Product Code / EMDN
M03040299
Device Name
Cooling Bandage
Database Sync Date
2026-08-09 17:01:24

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 DermaPlast ACTIVE Coolfix?

The registered manufacturer of record for DermaPlast ACTIVE Coolfix is IVF HARTMANN AG.

What is the Primary UDI-DI identifier for DermaPlast ACTIVE Coolfix?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 07611600996865.

What classification code is assigned to this device?

This device is registered under product classification code M03040299.

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