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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 Polymyositis/Scleroderma — 5 UDI-DI variants, IVDR

MD Atlas
D-tek s.a.

Data from EUDAMED, last updated May 23, 2026

BlueDot Polymyositis/Scleroderma

542502368BDPMSCLCN

5 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: 542502368BDPMSCLCN
Device name: —
Device model: BlueDot Polymyositis/Scleroderma
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class B
Version date: Nov 13, 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

5 UDI-DI variants

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Applied filters

basicUdiUlid01K9YNE5JGXSREYFWDMFK6VSPV

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

BlueDot Polymyositis/Scleroderma12 IgG05425023680681
BlueDot Polymyositis/Scleroderma8 IgG05425023680551
DiaSpotPolymyositis/Scleroderma8 IgG05425023688090
Sclero-Poly- Synthetase Profile 12 Ag Dot05425023687277
Sclero-Poly- Synthetase Profile 8 Ag Dot05425023687260