GUDIDData
eudamed_udi Primary ID: 04048534002448

DiaSpect Control Pack HBT4 (UDI 04048534002448)

Manufactured by EKF-diagnostic GmbH

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for DiaSpect Control Pack HBT4 - Primary ID 04048534002448

Device Regulatory Overview

The DiaSpect Control Pack HBT4 (Model/Catalog Number: 3200-6114) is a medical device manufactured by EKF-diagnostic GmbH. This product is indexed under FDA Product Code / Category Classification W0103010504 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
3200-6114
Product Code / EMDN
W0103010504
Device Name
DiaSpect Control HBT
Database Sync Date
2026-08-09 18:53:31

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 DiaSpect Control Pack HBT4?

The registered manufacturer of record for DiaSpect Control Pack HBT4 is EKF-diagnostic GmbH.

What is the Primary UDI-DI identifier for DiaSpect Control Pack HBT4?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 04048534002448.

What classification code is assigned to this device?

This device is registered under product classification code W0103010504.

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