GUDIDData
eudamed_udi Primary ID: 05425023687420

ENA Screen Dot for BDI (UDI 05425023687420)

Manufactured by D-tek s.a.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for ENA Screen Dot for BDI - Primary ID 05425023687420

Device Regulatory Overview

The ENA Screen Dot for BDI (Model/Catalog Number: AD ENASDBD) 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
AD ENASDBD
Product Code / EMDN
W0102100101
Device Name
BlueDiver Dot ANA Screening
Database Sync Date
2026-08-09 16:46:14

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 ENA Screen Dot for BDI?

The registered manufacturer of record for ENA Screen Dot for BDI is D-tek s.a..

What is the Primary UDI-DI identifier for ENA Screen Dot for BDI?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 05425023687420.

What classification code is assigned to this device?

This device is registered under product classification code W0102100101.

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