GUDIDData
eudamed_udi Primary ID: 05404013000982

S.Box HEATED TUBE (UDI 05404013000982)

Manufactured by Plastiflex Group NV

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for S.Box HEATED TUBE - Primary ID 05404013000982

Device Regulatory Overview

The S.Box HEATED TUBE (Model/Catalog Number: HPE15018KT0030GI) is a medical device manufactured by Plastiflex Group NV. This product is indexed under FDA Product Code / Category Classification R02010401 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
HPE15018KT0030GI
Product Code / EMDN
R02010401
Device Name
Active non implantable respiratory devices.
Database Sync Date
2026-08-09 16:48:07

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 S.Box HEATED TUBE?

The registered manufacturer of record for S.Box HEATED TUBE is Plastiflex Group NV.

What is the Primary UDI-DI identifier for S.Box HEATED TUBE?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 05404013000982.

What classification code is assigned to this device?

This device is registered under product classification code R02010401.

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