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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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BlueDiver Dot ANA Screening — 22 UDI-DI variants, IVDR (D-tek s.a.)

MD Atlas
D-tek s.a.

Data from EUDAMED, last updated May 23, 2026

BlueDiver Dot ANA Screening

542502368BDDANAYE

22 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: 542502368BDDANAYE
Device name: BlueDiver Dot ANA Screening
Device model: BlueDiver Dot
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class B
Version date: Oct 28, 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

22 UDI-DI variants

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Export results

Applied filters

basicUdiUlid01J8EXVHRAZ5VS6PVZRTWZH95Y

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 Dot for BDI05425023687307
ANA 12 Ag R Dot for BDI05425023687291
ANA Mi-2 Dot for BDI05425023687321
BlueDiverDot ANA + DFS-70 IgG05425023681695
BlueDiverDot ANA10 IgG05425023681312
BlueDiverDot ANA12 IgG05425023681329
BlueDiverDot ANA12 Screen IgG05425023681336
BlueDiverDot ANA8 IgG05425023681305
BlueDiverDot Connectivitis10 IgG05425023681411
BlueDiverDot ENA6 IgG05425023681442
BlueDiverDot PRL12 IgG05425023681794
Connectivitis Profile 10 Ag Dot for BDI05425023687383
DIASpot Neptune ANA10 IgG05425023688113
DIASpot Neptune ANA12 IgG05425023688120
DIASpot Neptune ANA12 Screen IgG05425023688137
DIASpot Neptune ANA8 IgG05425023688106
DIASpot Neptune Connectivitis 10 IgG05425023688175
DIASpot Neptune ENA 6 IgG05425023688199
ENA 10 Ag Dot for BDI05425023687406
ENA Dot for BDI05425023687413
ENA Screen Dot for BDI05425023687420
FULL ANA Dot for BDI05425023687437