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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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Swelab Alfa reagents — 6 UDI-DI variants, IVDR (Boule Medical AB)

MD Atlas
Boule Medical AB

Data from EUDAMED, last updated May 31, 2026

Swelab Alfa reagents

735004079A013YD

6 UDI-DI variants

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

Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Manufacturer: Boule Medical AB

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Device characteristics

ReagentProfessional testing

Identity & classification

Basic UDI-DI: 735004079A013YD
Device name: Swelab Alfa reagents
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Version date: Aug 10, 2025

Manufacturer & authorised representative

Manufacturer

Name: Boule Medical AB
SRN: SE-MF-000001911
Country: Sweden
Email: info@boule.com
Phone: +4687447700

Variants by status

UDI-DI variants

6 UDI-DI variants

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Export results

Applied filters

basicUdiUlid01K2AQN0NVTYCS0130D2G30R43

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

150412707350040790304
150446407350040796320
150412407350040790175
150446207350040796306
150412507350040790182
150446307350040796313