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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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BlueDiverDot Scleroderma — 4 UDI-DI variants, IVDR (D-tek s.a.)

MD Atlas
D-tek s.a.

Data from EUDAMED, last updated May 23, 2026

BlueDiverDot Scleroderma

542502368BDDSCLERODERMAKH

4 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: 542502368BDDSCLERODERMAKH
Device name: —
Device model: BlueDiverDot Scleroderma
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class B
Version date: Nov 24, 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

4 UDI-DI variants

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Applied filters

basicUdiUlid01KATX80FQZTZCEXCVV7BJPSXR

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

BlueDiverDot Scleroderma10 IgG05425023681725
BlueDiverDot Scleroderma12 IgG05425023681800
Scleroderma Profile 10 Ag Dot for BDI05425023687543
Scleroderma Profile 12 Ag Dot for BDI05425023687550