GUDIDData
eudamed_udi Primary ID: 05425023681329

BlueDiver Dot ANA12 IgG (UDI 05425023681329)

Manufactured by D-tek s.a.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for BlueDiver Dot ANA12 IgG - Primary ID 05425023681329

Device Regulatory Overview

The BlueDiver Dot ANA12 IgG (Model/Catalog Number: ANA12DIV-24) is a medical device manufactured by D-tek s.a.. This product is indexed under FDA Product Code / Category Classification W0102100101 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
ANA12DIV-24
Product Code / EMDN
W0102100101
Device Name
BlueDiver Dot ANA
Database Sync Date
2026-08-09 16:47:34

Full Regulatory Attributes

đź”’ 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 BlueDiver Dot ANA12 IgG?

The registered manufacturer of record for BlueDiver Dot ANA12 IgG is D-tek s.a..

What is the Primary UDI-DI identifier for BlueDiver Dot ANA12 IgG?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 05425023681329.

What classification code is assigned to this device?

This device is registered under product classification code W0102100101.

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