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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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BlueDot ANA Screening — 18 UDI-DI variants, IVDR (D-tek s.a.)

MD Atlas
D-tek s.a.

Data from EUDAMED, last updated May 23, 2026

BlueDot ANA Screening

542502368BDANAZF

18 UDI-DI variants

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]IVDR Class B

Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class B
Manufacturer: D-tek s.a.

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Device characteristics

ReagentProfessional testingAnimal tissues / cells

Identity & classification

Basic UDI-DI: 542502368BDANAZF
Device name: BlueDot ANA Screening
Device model: BlueDot
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class B
Version date: Sep 30, 2025

Manufacturer & authorised representative

Manufacturer

Name: D-tek s.a.
SRN: BE-MF-000024530
Country: Belgium
Email: cfrancois@d-tek.be
Phone: +3265841888

Variants by status

UDI-DI variants

18 UDI-DI variants

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Applied filters

basicUdiUlid01K6D6S0G839JY3NC34GN65H1V

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

ANA + DFS70 IgG Dot05425023687000
ANA Mi-2 Dot05425023687024
Connectivitis Profile 10 Ag Dot05425023687086
ENA Dot05425023687116
ENA Screen Dot05425023687123
FULL ANA Dot05425023687130
BlueDot ANA + DFS-70 IgG05425023680735
BlueDot ANA10 IgG05425023680315
BlueDot ANA12 IgG05425023680322
BlueDot ANA12 Screen IgG05425023680339
BlueDot ANA8 IgG05425023680308
BlueDot Connectivitis10 IgG05425023680575
BlueDot ENA6 IgG05425023680414
DiaSpot ANA10 IgG05425023688014
DiaSpot ANA12 Screen IgG05425023688021
DiaSpot ANA8 IgG05425023688007
DiaSpot ENA6 IgG05425023688045
ENA 10 Ag Dot05425023687109